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Issue 2 - Jan. 11, 2019
TCL45-02 (284 downloads)
Issue 1 - Jan. 4, 2019
TCL45-01 (47 downloads)

  • Real-World Evidence

    Fulfilling 21st Century Cures mandate, FDA lays out philosophy on real-world evidence—and recruits Amy Abernethy for No. 2 job

    FDA has created a framework for evaluating the use of real-world evidence to support additional indications for already approved drugs as well as to satisfy drug post-marketing study requirements.

  • Conversation with The Cancer Letter

    Amy Abernethy to join FDA as principal deputy commissioner

    Amy Abernethy, a thought leader in the field of evidence generation and the development of real-world evidence, was named principal deputy commissioner at FDA.

    Abernethy, who is now the chief medical officer, chief scientific officer and senior vice president of oncology at Flatiron Health, is expected to start at the agency in February 2019 after leaving Flatiron. She will replace Rachel Sherman, who oversees clinical, scientific, regulatory, and operational medical programs and initiatives across the agency. Sherman is retiring after 30 years of service at FDA.

  • An Appreciation

    Waun Ki Hong, Mentor Magnificus

    (Aug. 14, 1942 – Jan. 2, 2019)

    Yesterday, I received a succession of phone calls through the afternoon and evening—from Roy Herbst, chief of medical oncology at the Yale Cancer Center, Marge Foti, president of the American Association for Cancer Research, Patrick Hwu, head of the Division of Cancer Medicine at the MD Anderson Cancer Center (MDACC), and Otis Brawley, professor of oncology at Johns Hopkins University.

  • An Appreciation

    Waun Ki Hong, eminent role model, was always years ahead of the field

    This week, we lost a cancer research pioneer, and friend and mentor to many in the field, with the sudden death of Waun Ki Hong, M.D., a world-renowned clinical researcher who leaves behind a remarkable legacy.

  • An Appreciation

    A general in BATTLE, Waun Ki Hong was a pioneer of precision medicine

    I was heartbroken to learn of the passing of my mentor, colleague, and friend, Waun Ki Hong. Dr. Hong was the quintessential physician scientist who specialized in all aspects of medicine, but most notably patient care, research, and education. This is a devastating loss for the entire oncology community, and especially for all of the patients he cared for and helped.

  • The 25 most-read stories in The Cancer Letter in 2018

    We thought you might want to see what your colleagues in oncology have been reading. So, we went through our analytics to bring you a list of 25 of The Cancer Letter’s most-read stories of 2018.

  • In Brief

    • Lori Pierce elected ASCO president for 2020-2021
    • Community Oncology Alliance elects new officers and board members
    • José Baselga resigns from position of editor-in-chief of Cancer Discovery
    • BMS to acquire Celgene
    • Moffitt recruits five researchers

  • Funding Opportunities

    ACS and MRA fund $4 million in grants on metastasis in melanoma, other cancers

    The American Cancer Society and the Melanoma Research Alliance have partnered to support research by requesting grant applications involving interdisciplinary teams to better understand and manage metastasis of melanoma and other types of cancer.

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  • Clinical Roundup

    • Study finds elevated risk of rare blood cancers after chemo for most solid tumors
    • Study: Methods for reporting toxicities in cancer trials are falling short
    • Astellas, Pfizer announce positive top-line results from trial of XTANDI in mHSPC
    • G1 Therapeutics announces positive topline results from phase II trial of trilaciclib in SCLC
    • JAVELIN Ovarian 100 trial of avelumab fails to support initial hypothesis

  • Drugs & Targets

    • Lynparza gets FDA approval for first-line maintenance in BRCA-mutated advanced ovarian cancer
    • Sprycel approved in combination with chemo pediatric Ph+ ALL
    • Keytuda approved for recurrent locally advanced or metastatic MCC
    • Merck provides update on Keytruda sBLA for KEYNOTE-042 trial
    • Keytruda receives five approvals in Japan
    • FoundationOne CDx receives regulatory approval in Japan
    • FDA approves longer-acting calaspargase pegol-mknl for ALL
    • GRANITE-001 gets FDA Fast Track for colorectal cancer

  • NCI Trials

    NCI Trials for January

    The National Cancer Institute Cancer Therapy Evaluation Program approved the following clinical research studies last month.

    For further information, contact the principal investigator listed.

Issue 46 - Dec. 14, 2018
TCL44-46 (296 downloads)

  • An Appreciation

    Howard Ozer died as he lived—on a safari

    Around March, my friend Howard Ozer told me he was heading out on a safari. He did these things often, adding to his collection of trophies.

  • Guest Editorial

    Conflicts have killed trust in the system. Advocates must rebuild it

    Breast cancer research is big business. And the incentives in that business are designed to benefit industry, doctors and institutions, leaving patients behind. In 2018 alone, about $1 billion federal dollars were invested in institutions around the country to fund research.

  • In Brief

    • Anil Rustgi named cancer center director at Columbia, New York-Presbyterian
    • Jasmin Tiro to focus on assessing, meeting cancer needs in Dallas/Fort Worth area
    • Leigh Boehmer named medical director of education at the ACCC
    • Pentecost Foundation gifts $3 million to Moffitt

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  • Clinical Roundup

    • Kadcyla cut risk of disease recurrence vs. Herceptin in HER2-positive early breast cancer with residual disease after neoadjuvant treatment
    • BYL719 + fulvestrant improved PFS in PIK3CA mutated HR+/HER2- advanced breast cancer
    • Data show efficacy, tolerability of Kisqali combination in HR+/HER2- advanced breast cancer with visceral disease
    • Insight Genetics launches test for triple negative breast cancer
    • Biotheranostics presents data on the Breast Cancer Index
    • First-line immunotherapy combination fails to improve OS in lung cancer
    • Amifostine delays onset of acute esophagitis for small cell lung cancer patients

  • Drugs & Targets

    • European Commission adopted positive opinion of rucaparib in platinum-based chemotherapy
    • FDA grants orphan drug designation to Merck’s M7824 in biliary tract cancer
Issue 45 - Dec. 7, 2018
TCL44-45 (260 downloads)

  • NCI cuts programs by 5% and non-competing renewals by 3% to maintain paylines in fiscal 2019

    NCI is cutting the budgets of divisions, offices, and centers within the institute by 5 percent to maintain funding for its Research Project Grant pool, which funds a broad range of basic research, as well as clinical trials and health services research.

  • Conversation with The Cancer Letter

    UAB Cancer Center receives $30 million naming gift from O’Neal Industries

    The University of Alabama at Birmingham Comprehensive Cancer Center has received a $30 million gift from O’Neal Industries Inc., a family-owned global business based in Birmingham.

  • In Appreciation

    Lisa Schwartz, expert in overtreatment and pathbreaking educator, dies at 55

    Lisa Schwartz, professor of Medicine and of Community and Family Medicine at Dartmouth Medical School died on November 29 after a seven-year struggle with cancer—a terrible loss to all who knew her.

  • Obituary

    Charles A. Coltman Jr., long-time SWOG chair and co-founder of the San Antonio Breast Cancer Symposium, dies at 88

    Charles A. Coltman Jr., a pioneer of treatment of leukemia and lymphoma, a long-time chair of SWOG, and a co-founder of the San Antonio Breast Cancer Symposium, died after a long illness on Nov. 28. He was 88.

  • In Brief

    • Wafik El-Deiry to lead cancer biology program at Brown 
    • Emory Proton Therapy Center opens

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  • Clinical Roundup

    • Kite announces two-year data for Yescarta in patients with refractory large B-cell lymphoma
    • Kite announces updated data from ZUMA-3 study of KTE-X19 in adult patients with relapsed or refractory ALL 
    • Ibrutinib + rituximab superior to standard treatment for some patients with CLL
    • Data from phase I/II open-label study of BCMA-directed CAR-T cell therapy lcar-b38m show tolerable safety profile, high response and MRD-negative rate in advanced r/r multiple myeloma
    • New long-term data on acalabrutinib in mantle cell lymphoma and CLL
    • Geron announces OS data from IMbark in Imetelstat-treated patients with intermediate or high-risk myelofibrosis and r/r to JAK inhibitor
    • New long-term data on Calquence presented
    • Combination immunotherapy shows high activity against recurrent Hodgkin lymphoma
    • Karyopharm reports positive top-line phase IIb SADAL data for Selinexor in diffuse large B-cell lymphoma
    • Celgene announces initial phase I/II liso-cel data in patients with r/r CLL

  • Drugs & Targets

    • FDA approves Tecentriq + Avastin and carboplatin for initial treatment of specific type of metastatic lung cancer
    • FDA publishes draft guidance on class labeling of in vitro companion diagnostics for classes of drugs in oncology
    • FDA publishes framework document on real-world evidence

  • NCI Trials

    NCI Trials for December

    The National Cancer Institute Cancer Therapy Evaluation Program approved the following clinical research studies last month.

Issue 44 - Nov. 30, 2018
TCL44-44 (233 downloads)

  • FDA approves second drug for a site-agnostic indication; larotrectinib was tested across 17 cancer types

    Vitrakvi (larotrectinib) aims to treat a very small group of people—some say fewer than 3,000 new patients a year in the U.S. And since these patients have diseases that span multiple tumor sites, finding them isn’t easy.

  • How we isolated the TRK oncogene

    I was very surprised to see in an issue of the NEJM earlier this year that Loxo Oncology had developed a selective TRK inhibitor, larotrectinib, and even more surprised to learn that TRK fusions occur in about 1 percent of all human cancers.

  • Conversation with The Cancer Letter

    Hyman: “This approval adds to the growing utility of sequencing in patients with cancer”

    As Vitrakvi (larotrectinib) becomes the second drug to get FDA approval for a site-agnostic indication, physicians will have yet another reason to order sequencing, said David Hyman, chief of the Early Drug Development Service at Memorial Sloan Kettering Cancer Center and the principal investigator for a larotrectinib clinical trial that led to the approval. 

  • Cancer groups: CMS proposal to lower drug prices would limit access for patients in “protected classes”

    The Centers for Medicare and Medicaid Services has proposed a drug-pricing plan that administration officials say would offer lower cost options to seniors and provide support for the private sector to lower the cost of prescription drugs.

  • Guest Editorial

    Reasons for hope for acute myeloid leukemia patients

    On the eve of the Thanksgiving holiday, FDA delivered a flurry of decisions: approvals for two therapies—venetoclax and glasdegib—to treat a deadly form of blood cancer called acute myeloid leukemia (AML), and a priority review designation for another therapy—quizartinib—to treat the same disease. A fourth therapy to treat AML—gilteritinib—received an FDA approval on Nov. 28.

  • In Brief

    • The Pancreatic Cancer Collective awards $7 million in first-round “New Therapies Challenge” grants
    • Oren Cahlon named associate deputy physician-in-chief of MSK’s Regional Care Network
    • Weill Cornell Medicine awarded $9 million grant for mantle cell lymphoma research
    • UPenn’s Abramson Cancer Center joins NCCN as member institution
    • New CPRIT Scholar Grants recruit talent to Texas institutions
    • Huntsman Cancer Institute breaks ground for Utah’s first proton therapy center
    • David Kerstein named chief medical officer of Anchiano Therapeutics

  • TCCL Logo

  • Clinical Roundup

    • Brain cancer immunotherapy SurVaxM extends survival
    • Avelumab in platinum-resistant/refractory ovarian cancer did not meet OS and PFS endpoints

  • Drugs & Targets

    • FDA grants Venclextra accelerated approval for newly-diagnosed AML
    • FDA approves Daurismo for newly-diagnosed AML in adults 75 years and older
    • FDA approves gilteritinib for relapsed or refractory AML with a FLT3 mutation
    • FDA approves Truxima as biosimilar to Rituxan for non-Hodgkin’s lymphoma
Issue 43 - Nov. 16, 2018
TCL44-43 (1316 downloads)

  • Artificial intelligence can entrench disparities—here’s what we must do

    Heinz Von Foerster, the renowned Austrian-American physicist and cybernetics scholar, declared that “information can be considered as order wrenched from disorder.1” Ever-increasing amounts of digital data and new computational tools promise that technological developments such as artificial intelligence (AI) will bring order, clarity, and new solutions in multiple areas—from transportation to criminal justice.

  • Guest Editorial

    Trump pricing plans are pretentious, could impede access, and will not help much

    Oct. 25, we heard more about President Trump’s plan to save health care dollars through a variety of Medicare pilot programs and index pricing.

  • In Brief

    • Cornelis Melief receives 2018 ESMO Immuno-Oncology Award
    • Roswell Park partners with Jagiellonian University in Kraków
    • NCCS presents third annual Ellen Stovall Award to Gay Crawford and Norman Coleman
    • IU researchers awarded $2.3 million to continue studies on CIPN
    • UVA researchers awarded $1.8 million to test breast cancer approach

  • TCCL Logo

  • Trials & Tribulations

    Deciphering genomic testing options for diverse patient populations in early-stage breast cancer

    In my twenty-two years of practicing medicine, I have observed the evolution of genomic testing and its increasing utility in oncology.

    With the growing interest in precision medicine for breast cancer patients, I have found it important to decipher the differences between the two most clinically validated genomic tests, MammaPrint and Oncotype DX, and their phase III trials, MINDACT and TAILORx, respectively.

  • Clinical Roundup

    • Cardiovascular toxicities seen early in treatment with immune checkpoint inhibitors
    • Breast screening linked to 60 percent lower risk of breast cancer death in first 10 years
    • Fecal transplant effective against immunotherapy-induced colitis
    • Biodesix test predicts response to atezolizumab in lung cancer
    • Keytruda significantly improved OS compared to chemotherapy in PD-L1 advanced esophageal or esophagogastric junction carcinoma
    • Pfizer introduces biosimilar Retacrit injection in the U.S. at a substantial discount
    • Initial data from AMBER trial of TSR-022 + TSR-042 demonstrates clinical activity in progression following anti-PD-1 treatment
    • Zymeworks announces updated clinical data for novel bispecific antibody, ZW25
    • Gradalis presents initial data from phase II U.S. trial for Ewing’s sarcoma

  • Drugs & Targets

    • Using review pilot program, FDA takes two weeks to approve first-line treatment for peripheral T-cell lymphoma
    • FDA accepts novel clinical trial endpoint in approving Erleada for prostate cancer
    • CHMP gives positive opinion for Kisqali combination therapy for all women with HR+/HER2- locally advanced or metastatic breast cancer
    • FDA grants priority review for Tecentriq + Abraxane for metastatic triple-negative breast cancer
    • Immunomedics expands clinical collaboration with AstraZeneca to include metastatic NSCLC
    • Ziopharm Oncology announces Immuno-oncology Clinical Supply Agreement with Regeneron to evaluate combination therapy for brain cancer
Issue 42 - Nov. 9, 2018
TCL44-42 (298 downloads)

  • Otis Brawley leaves the American Cancer Society as it pursues “open-for-business” strategy amid sliding revenues

    If you walked into your local Long John Silver’s restaurant on Sept. 19 and attempted to “talk like a pirate,” the person behind the counter would give you a free deep-fried Twinkie and prompt you to count out a few coins for the American Cancer Society.

  • Conversation with The Cancer Letter

    Brawley: “I started out talking about black-and-white disparities, and now I write papers talking about state-by-state disparities”

    I wish more Americans would care about other Americans and their health care. I see a certain amount of selfishness sometimes, especially when we start having these arguments about screening.

  • Conversation with The Cancer Letter

    Jaffee: Congressional commitment to NIH will continue through FY2021

    The growing nation’s budget deficit will become a primary focus for many in Congress and President Trump, potentially resulting in calls to cut spending, and thereby effectively capping the rate of growth that the NIH budget has experienced during the past four years. In fact, the president has already called for a 5 percent cut across all departments in FY 2020.

  • An Appreciation

    Arti Hurria, geriatric oncologist at City of Hope, dies in traffic accident

    Arti Hurria, a pioneer of geriatric cancer care at City of Hope, died Nov. 7 in a traffic accident. She was 48.

  • Letter to the Editor

    On behalf of ECOG-ACRIN, we want to add our voices to the condolences for the families and community of those killed in Pittsburgh. We paraphrase the assertion of Edmund Burke that all that is required for evil to triumph is that good people remain silent. In response, as a community dedicated to the relief of suffering, we register our condemnation of this atrocity, and of all those that would prey upon sub-populations of our diverse society.

  • In Brief

    • Richard M. Schulze Family Foundation gives $6 million to Moffitt
    • Paul G. Allen Frontiers Group announces Allen Distinguished Investigators

  • TCCL Logo

  • Clinical Roundup

    • Stereotactic radiosurgery and surgical resection offer similar local control of brain metastases
    • Trisalus pressure-enabled drug delivery increased effect of anti-CEA CAR-T in pancreatic cancer patients with liver metastases

  • Drugs & Targets

    • FDA approves Empliciti + pomalidomide and dexamethasone for multiple myeloma
    • FDA grants Fast Track to selinexor for diffuse large B-cell lymphoma
    • Seattle Genetics submits sBLA for ADCETRIS in frontline treatment of CD30-expressing peripheral T-cell lymphomas
    • BMS, Infinity form collaboration to evaluate Opdivo + IPI-549 in urothelial cancer
    • ASCO, SITC release recommendations for reporting of immuno-oncology clinical trials
    • Sandoz decides not to pursue US biosimilar rituximab
    • FDA’s digital tool seeks to help capture real world data useful in regulatory decision-making
    • Elsevier to integrate NCCN guidelines into Via Oncology
Issue 41 - Nov. 2, 2018
TCL44-41 (1320 downloads)

  • Minimally invasive surgery lowers survival in cervical cancer, new studies show

    Women who were subjected to minimally invasive surgery for early-stage cervical cancer were four times more likely to die from that disease within three years, three times more likely to have a recurrence within three years, and had shorter overall survival, compared to women who underwent open surgery, according to two groundbreaking studies published in The New England Journal of Medicine Oct. 31.

  • Conversation with The Cancer Letter

    Ramirez: We no longer offer minimally invasive radical hysterectomy at MD Anderson

    When cervical cancer patients were referred to MD Anderson Cancer Center for a prospective, phase III trial testing for noninferiority of minimally invasive vs. open abdominal radical hysterectomy, many requested the minimally invasive approach, because their referring physicians said it was better, said Pedro Ramirez, a professor of gynecologic oncology at MD Anderson.

  • Conversation with The Cancer Letter

    SGO’s Kesterson: Future studies are needed to define role of minimally invasive surgery in cervical cancer

    Gynecologic oncologists need to reduce oncologic risk, but it’s not going to happen without knowing why minimally invasive radical hysterectomies decrease survival of patients with cervical cancer, said Joshua Kesterson, chief of the Division of Gynecologic Oncology at Penn State  Cancer Institute.

  • Experts: Minimally invasive procedures in gynecology gained universal acceptance before hard questions were asked

    I think these investigators should be commended in doing this trial and coming up with these results. It shows that, in a clear way, we can’t make assumptions in anything we do. The assumption that robotic surgery would be just as good as open surgery is clearly demonstrated here that it’s not a fair assumption.

  • Conversation with The Cancer Letter

    Waksal: Reflecting on the Tree of Life shooting and new American anti-Semitism

    It made me step back and think that things can happen anywhere, and when they happen, it certainly makes one take pause and think, life is fragile in that way as a Jew anywhere, and anti-Semitism has been more in the news than it ever was.

  • In Brief

    • Barry Kramer retires from NCI
    • Adam Margolin to lead new $200M program to accelerate precision medicine at Mount Sinai
    • Andrzej Dlugosz to oversee basic science research at Rogel Cancer Center
    • Leonard Freedman named chief science officer at Frederick National Laboratory
    • Johnathan Whetstine to lead Cancer Epigenetics Program at Fox Chase
    • Syapse to utilize NCCN Biomarkers Compendium for clinical care
    • ONS and other groups ask nurses to lead by example to promote advance care planning
    • SU2C announces fundraising at CVS pharmacies

  • Funding Opportunities

    Global challenge aims to open new direction in breast cancer research

    The California Breast Cancer Research Program has launched the Global Challenge to Prevent Breast Cancer, a competition designed to surface game-changing research ideas to advance breast cancer prevention.

  • TCCL Logo

  • Clinical Roundup

    • Survey shows 4 in 10 Americans believe alternative therapies can cure cancer
    • Study identifies factors for reducing risk of immunosuppression, fever in people treated with chemotherapy

  • Drugs & Targets

    • FDA approves Keytruda + carboplatin and either paclitaxel or nab-paclitaxel for first-line metastatic squamous NSCLC
    • FDA accepts sNDA for Lonsurf for metastatic gastric/gastroesophageal junction adenocarcinoma; grants Priority Review
    • Venclexta + Gazyva reduced risk of disease worsening or death in previously untreated CLL with co-morbidities
    • TESARO achieves Zejula prostate cancer development milestone by Janssen
    • Cofactor Genomics launches ImmunoPrism kit for use in clinical sequencing laboratories

  • NCI Trials

    NCI Trials for November

    The National Cancer Institute Cancer Therapy Evaluation Program approved the following clinical research studies last month.

    For further information, contact the principal investigator listed.

Issue 40 - Oct. 26, 2018
TCL44-40 (271 downloads)

  • Long-awaited trial of checkpoint inhibitor in breast cancer produces 2-month PFS gain; no final OS advantage seen—yet

    Tecentriq, Genentech’s PD-L1 checkpoint inhibitor, is the first immunotherapy agent to report positive outcomes in breast cancer in a phase III trial—providing proof of principle that these drugs are active in treatment of triple-negative breast cancer.

  • Conversation with The Cancer Letter

    NCI’s Korde: Follow-up needed to validate PFS with mature OS results for Tecentriq

    In talking to patients, I think it’s difficult to ignore the possibility of a 10-month improvement in overall survival in patients with PD-L1 positive tumors. If this result is confirmed with longer follow-up and seen in future studies, it would certainly be a major step forward in the treatment of TNBC.

  • Has Tecentriq earned a role in treatment of triple-negative breast cancer? Here is what experts say

    Obviously, the field of immune-oncology has been one of the great success stories in our field over the last five years, based on our molecular understanding of the mechanisms of immune tolerance (or checkpoints) and how to disrupt that. Not only has ASCO declared Checkpoint Inhibition (as well as cellular-based immunotherapy) the “Advance of the Year,” the Nobel Committee awarded this year’s Prize to Drs. Allison and Honjo for their fabulous observations that led to these great breakthroughs.

  • Trump’s drug pricing plan pegs Medicare Part B payments to international levels

    The Trump administration earlier this week said it intends to start the rulemaking process aimed at aligning Medicare payments for drugs with prices paid outside the US.

  • In Brief

    • Ken Cowan to step down as director of Nebraska’s Fred & Pamela Buffett Cancer Center
    • Otis Brawley, Patricia Ganz, James Wade receive ACCC awards
    • Taylor Ripley to join Baylor College of Medicine
    • Alastair Thompson to lead breast surgical oncology at BCM
    • Rutgers’s Richard Drachtman receives Melvyn H. Motolinsky Award
    • Mount Sinai mammography van intended to break down disparities in screening

  • TCCL Logo

  • Clinical Roundup

    • Keytruda improved OS as monotherapy and in combination with chemo in first-line recurrent or metastatic head and neck cancer
    • Keytruda shows nearly 40% CR in high-risk non-muscle invasive bladder cancer unresponsive to standard of care
    • Loxo Oncology announces larotrectinib clinical update in patients with TRK Fusion cancers
    • Pfizer provides update on PALOMA-3 trial of IBRANCE in HR+, HER2- metastatic breast cancer
    • Data monitoring committee recommends continuation of SGX301 trial in cutaneous T-cell lymphoma
    • Data on Merck’s investigational STING agonist presented at ESMO 2018
    • Zoledronic acid improves DFS in premenopausal HR+ early breast cancer
    • SOLO-1 phase III trial demonstrates Lynparza maintenance therapy cut the risk of disease progression or death by 70% in advanced BRCA-mutated ovarian cancer
    • Study shows surgery, radiation extend survival of patients with limited metastatic lung cancer
    • Lonsurf meets OS and PFS endpoints in phase III trial
    • AVEO Oncology, EUSA Pharma announce updated interim results from phase II portion of the TiNivo study in renal cell carcinoma
    • Celsion announces PFS data from GEN-1 phase I immuno-oncology study in stage III/IV ovarian cancer
    • Study: Racial disparity in colorectal cancer incidence not due to biology
    • Marker found for condition that causes skin tumors

  • Drugs & Targets

    • FDA accepts sNDA for Lonsurf for metastatic gastric/gastroesophageal junction adenocarcinoma; grants Priority Review
    • BMS provides update on regulatory review of Opdivo + Yervoy in first-line lung cancer
    • Zai Lab announces approval of Zejula in relapsed ovarian cancer in Hong Kong
    • NCCN awarded $2M to study Taiho’s Trifluridine and Tipiracil in various cancers
Issue 39 - Oct. 19, 2018
TCL44-39 (279 downloads)
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