Home – Page 40 – The Cancer Letter

Issue 30 - Jul 27, 2018

TCL44-30 (1130 downloads)

New drugs and new ideas are transforming AML
An actuary might note that if you were in residency at the time when the 7+3 protocol of cytarabine and daunorubicin was first used to treat acute myelogenous leukemia, chances are you are considering retirement just about now.
Conversation with The Cancer Letter
OSU’s Byrd: “It’s becoming necessary to consult with an expert, because it is complicated, and things are moving”
As the landscape in acute myelogenous leukemia changes, consultations with top-tier experts have become a necessity, said John Byrd, the principal investigator of Beat AML, Distinguished University Professor, the D. Warren Brown Professor of Leukemia Research at The Ohio State University, a member of the NCI Leukemia Steering Committee, chair of the Leukemia and Correlative Science Committee within the Alliance for Clinical Trials in Oncology.
Conversation with The Cancer Letter
Agios’s Schenkein: “It’s not one disease. Just like lung cancer’s not one disease”
Agios Pharmaceuticals Inc., the sponsor of two drugs that may change the outcomes for a subset of acute myelogenous leukemia patients, is focused on more than AML.
FDA will organize new review divisions around disease types, Gottlieb testifies
To modernize drug development, FDA plans to add review divisions to its Center for Drug Evaluation and Research and organize those divisions around disease types, FDA Commission Scott Gottlieb said July 25 to members of Congress in a House Energy and Commerce Committee hearing.
In Brief
- DuBois, Pollak named editors of Cancer Prevention Research
- Walker named new COO of City of Hope
- Manotti named senior vice president, chief development officer at MSKCC
- Agarwal named chief medical officer at Epizyme
- IU’s Broxmeyer receives NHLBI Outstanding Investigator Award
- Royce, Kircher selected for ASCO’s 2018-2019 Health Policy Fellowship Program
Clinical Roundup
- UCLA’s Yang receives $1.4M to develop cellular therapy using blood stem cells
- Takeda’s Alunbrig meets PFS primary endpoint
Drugs & Targets
- FDA approves magnetic device system for sentinel biopsies in breast cancer
- FDA accepts Celyad IND application for CYAD-101, a non-gene edited allogeneic CAR-T candidate
- Keytruda approved in China for advanced melanoma
- BMS, Tsinghua University to develop therapies for autoimmune diseases, cancer

Issue 29 - Jul 20, 2018

TCL44-29 (270 downloads)

Pilot programs aim to revamp cancer drug approval process—from completion of trial to ODAC presentation
FDA is revamping the gearing in the machinery of approval of cancer drugs, making it possible to initiate regulatory review immediately after the clinical trials datasets are locked.
Conversation with The Cancer Letter
Novartis’s Hirawat: “It’s a continuous dialogue that goes on on a daily basis”
The two FDA pilot programs—Real-Time Oncology Review and Assessment Aid sped up the processing of Novartis’s supplemental new drug applications for Kisqali (ribociclib), said Samit Hirawat, executive vice president and head of Global Oncology at Novartis.
FDA spells out rules for new endpoint: Metastasis-free survival
It’s official, FDA is recognizing a new endpoint that seems especially well suited for prostate cancer: metastasis-free survival, or MFS for short.
Conversation with The Cancer Letter
Julia Beaver: SPARTAN and PROSPER showed MFS improvements greater than 20 months
The endpoint of metastasis-free survival is unlikely to be used in settings beyond non-metastatic castration-resistant prostate cancer, said Julia Beaver, director of Division of Oncology Products 1 at the FDA Center for Drug Evaluation and Research.
Conversation with The Cancer Letter
Maha Hussain: OS isn’t a practical endpoint in the context where patients are likely to live 10 years or more
As a veteran of the FDA Oncologic Drugs Advisory Committee, Maha Hussain took part in the group’s past discussions on treatment options for men with non-metastatic castration-resistant prostate cancer.
An Appreciation
Marlene McCarthy, formidable Breast Cancer Coalition advocate, dies at 74
There are so few individuals who are willing to challenge authority in the world of cancer advocacy. Marlene McCarthy was one of the best at that. Marlene died on July 17; she was 74.
Marlene was a fighter. Over the years I have seen so many women and men shy away from questioning the approach of a member of Congress and from speaking out when a policy was watered down to the point of being meaningless.
In Brief
- NCI, NIMHD, PCF launch $26.5M study on aggressive prostate cancer in African-American men
- NCCS receives grant to develop “Return to Functional Status” outcome measure
- Loretta Li and Avery Posey receive CureSearch Young Investigator Award
- American Academy of Nursing inducts 2018 fellows
Funding Opportunities
DOD Breast Cancer Research Program Breakthrough Awards
FY18 BCRP Program Announcements and General Application Instructions for the following award mechanisms are posted on Grants.gov.
Clinical Roundup
- FDA approves Tibsovo as first targeted treatment for relapsed or refractory AML
- Tecentriq + pemetrexed and chemotherapy reduced the risk of disease worsening or death in lung cancer
- Large disparities seen in cancer mortality rates among minority subpopulations in New York
- “Hijacked” cell response to stress reveals promising drug targets for blood cancer
- PD-1 inhibitors may improve immune response in early-stage NSCLC
- Complementary medicine for cancer can decrease survival
- Studies show daily aspirin use reduces ovarian cancer risk and improves survival after diagnosis
Drugs & Targets
- FDA grants breakthrough designation for Tecentriq + Avastin as first-line treatment for hepatocellular carcinoma
- FDA places partial clinical hold on Mersana clinical trial
- BMS and Gritstone to evaluate neoantigen immunotherapy in solid tumors

Issue 28 - Jul 13, 2018

TCL44-28 (265 downloads)

Immunologists seek ways to make TIL in solid tumors as effective as CAR T in blood cancers
For more than four decades, Steven Rosenberg’s work on tumor infiltrating lymphocytes has met with equal measures of skepticism and cheer—but now, as more patients across multiple cancer types respond to cell transfer immunotherapy, researchers are eager to join the movement Rosenberg indisputably leads.
Conversation with The Cancer Letter
NCI’s Rosenberg: Tumor infiltrating lymphocytes offer a strategy for treating recalcitrant solid cancers
After achieving complete regression in several patients with different solid tumor types, Steven Rosenberg is eyeing the biggest prize imaginable—advancing the therapies he has championed for over four decades into the clinic as treatments for commonly occurring cancers.
House committee proposes $1.25 billion raise for NIH
The fiscal year 2019 spending bill marked up by the House Committee on Appropriations gives NIH a $1.25 billion raise.
“The National Institutes of Health, our nation’s premier biomedical agency, is funded at $1.25 billion above last year’s appropriation,” said Rep. Tom Cole (R-OK), Labor-HHS subcommittee chair.
In Brief
- Gerstle named chief of Pediatric Surgery Service at MSK
- Pestell joins CytoDyn as chief medical officer
- Beck named COO at Leukemia & Lymphoma Society
- UCLA’s Ribas named “Great Immigrant” by Carnegie Corp.
- Abbott joins the Fox Chase Department of Diagnostic Imaging
Clinical Roundup
- ACA credited with earlier diagnosis of gynecologic cancers in young women
- Phase III trial of Ninlaro meets PFS primary endpoint in multiple myeloma
- New blood test measures four protein biomarkers, can help identify lung cancer
Drugs & Targets
- FDA grants accelerated approval to Yervoy for MSI-H or dMMR metastatic colorectal cancer
- FDA approves Xtandi sNDA for CRPC
- FDA grants Priority Review to Merck’s sBLA for Keytruda for advanced hepatocellular carcinoma
- Genentech submits sNDA for Venclexta for an AML indication

Page 40 of 118« First «...10 20 30...36 37 38 394041 42 43 44 45...60 70 80 90 100 110...»Last »