Home – Page 31 – The Cancer Letter

Issue 11 - Mar 15, 2019

TCL45-11 (301 downloads)

News Analysis
The Gottlieb-Sharpless-Lowy rearrangement
No prizes should be handed out to anyone who predicted that:
1. Scott Gottlieb would leave his job as FDA commissioner,
2. Gottlieb would suggest NCI Director Ned Sharpless as his replacement, and
3. NCI Deputy Director Doug Lowy would step in as NCI acting director.
Trump proposal for FY2020 to slash NIH by 12 percent, NCI by 15 percent
President Donald Trump has proposed to cut $4.7 billion from the NIH budget, with almost $900 million coming out of NCI during the fiscal year 2020.
AACR News
DuBois to receive Magaret Foti award; Freireich–Lifetime Achievement award; Hudson and Robison–Team Science award
The American Association for Cancer Researc will honor the following cancer researchers, clinicians, and physician-scientists at the AACR Annual Meeting 2019, to be held March 29-April 3 in Atlanta.
ASCO News
Hortobagyi to deliver Karnofsky lecture; Brugge–Science of Oncology lecture; Wolmark–Gianni Bonadonna lecture
The American Society of Clinical Oncology and ASCO’s Conquer Cancer Foundation announced the winners of Special Awards, the society’s highest honors, and Conquer Cancer’s Women Who Conquer Cancer Mentorship Awards.
In Brief
- Fred Hirsch to join Mount Sinai Tisch Cancer Institute
- Reps. Higgins, Guthrie, Matsui and Bilirakis announce the Cancer Drug Parity Act
- Ong named a finalist in the 25th Annual NIHCM Research and Journalism Awards
Conversation with The Cancer Letter
TMIST PI Pisano: “Are we further reducing breast cancer mortality the more intensively we screen?”
The Tomosynthesis Mammographic Imaging Screening Trial, a massive randomized trial of early detection, is asking an important question:
Is digital breast tomosynthesis better than digital mammography in reducing development of advanced breast cancer?
Clinical Roundup
- UAMS study shows potential to alter neck dissection surgery in head and neck cancer
Drugs & Targets
- European Commission approves Keytruda + chemotherapy for NSCLC
- Tecentriq + Abraxane regimen gets accelerated approval for breast cancer
- Trazimera, Herceptin biosimilar, gets FDA approval
- myPath melanoma test receives Medicare coverage

Issue 10 - Mar 8, 2019

TCL45-10 (467 downloads)

Trump’s proposal for pediatric cancer has NCI envisioning the first data federation of its kind
In anticipation of an infusion of funds from Congress, NCI is developing a blueprint for a comprehensive cancer data federation—starting with pediatric cancer.
Conversation with The Cancer Letter
Sharpless: With $500 million, NCI can create data federation that would change research in childhood cancer
If this effort is highly successful for childhood cancer, then we’ll broaden the efforts to other cancers next. This is an important first step in learning how useful radical data sharing and aggregation can be.
Conversation with The Cancer Letter
CHOP’s Resnick: Big data will transition from research to the standard of care in the clinic
It’s extremely exciting to hear and see both the NCI and the administration and other community partners and patient groups really coming together and reconsidering, ‘What are the unmet needs that can inform in new ways through new approaches of integration?
Conversation with The Cancer Letter
St. Jude’s Roberts: “No single institution can maximize cures and minimize toxicities alone”
Historically, cancer research drug development has largely been focused upon adult cancers with drugs trickling down to pediatric trials over time. But we now know that 55 percent of the driver mutations are unique to childhood cancers. So, relying upon that old model is not going to serve children well.
Guest Editorial
Needed: A fully funded data federation for pediatric cancer with deep genomic sequencing and clinical records
It was a thrilling moment for me when, sitting on my living room couch, listening to the State of the Union address, I heard the president say:
“Many childhood cancers have not seen new therapies in decades. My budget will ask the Congress for $500 million over the next 10 years to fund this critical life-saving research.”
Gottlieb resigns at FDA, recommends Sharpless as successor
Scott Gottlieb has submitted a letter of resignation from his job as FDA commissioner, reportedly recommending that NCI Director Ned Sharpless be appointed as his successor at the agency.
In Brief
- Raymond DuBois receives AACR Margaret Foti Award
- Charles Sawyers to present AACR Princess Takamatsu memorial lecture
- Alberto Mantovani receives Pezcoller Foundation-AACR Award
- Jeffrey Bluestone to receive AACR-Irving Weinstein Foundation lectureship award
- Manuel Hidalgo named chief of hematology and medical oncology at Weill Cornell
- Greg Delgoffe to receive Sy Holzer Endowed Immunotherapy Research Fund
Funding Opportunities
FDA Oncology Center of Excellence publishes research contract opportunities
The FDA Oncology Center of Excellence seeks white papers to award contracts for oncology regulatory science research through a Broad Agency Announcement, FDABAA-19-00123.
Clinical Roundup
- Genentech submits sNDA for Venclexta plus Gazyva for previously untreated CLL
- Study: AI may perform as well as radiologists
Drugs & Targets
- Paige.AI receives FDA Breakthrough Device designation
- Lynparza receives positive EU CHMP opinion in breast cancer
- Breast Cancer Index receives expanded Medicare coverage
NCI Trials
NCI Trials for March
The National Cancer Institute Cancer Therapy Evaluation Program approved the following clinical research studies last month.

Issue 9 - Mar 1, 2019

TCL45-09 (234 downloads)

ODAC gives thumbs down to single-arm trial of two-drug combination for multiple myeloma
Committee focuses on meaning of equipoise, accelerated approval, confirmatory trials
It’s not just the absence of a randomized trial that prompted the FDA Oncologic Drugs Advisory Committee to recommend against an accelerated approval of the Karyopharm Therapeutics Inc. drug selinexor for late-stage multiple myeloma.
FDA tightens regulation of robotic devices in minimally invasive surgery for cancer
Device manufacturers looking to market surgical tools for use in the prevention or treatment of cancer may now be required to study long-term oncologic endpoints in surgical trials, according to a safety communication published by FDA on Feb. 28.
In Brief
- NCORP networks to take part in NCI’s Moonshot Tissue Procurement Protocol
Conversation with The Cancer Letter
CDC: HPV vaccine dramatically reduced HPV-related cervical precancers over 6 years
The number of cases of HPV+ cervical precancers has dropped by 21 percent from 2008 to 2014, according to a survey by the Centers for Disease Control and Prevention.
Clinical Roundup
- BRACAnalysis CDx test identified patients with pancreatic cancer who benefitted from Olaparib
- PET scans show biomarkers could spare some breast cancer patients from chemotherapy
- Medicaid expansion in Kentucky led to more screening and higher CRC survival
- Study shows annual non-invasive stool test effective for colon cancer screening
- Lab-grown mini tumors could help identify personalized treatments for people with rare cancers
- Inherited mutations may play a role in development of pancreatic cancer
Drugs & Targets
- FDA approves new formulation of Herceptin
- FDA approves Lonsurf with GEJ adenocarcinoma

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News Analysis

The Gottlieb-Sharpless-Lowy rearrangement

Trump proposal for FY2020 to slash NIH by 12 percent, NCI by 15 percent

AACR News

DuBois to receive Magaret Foti award; Freireich–Lifetime Achievement award; Hudson and Robison–Team Science award

ASCO News

Hortobagyi to deliver Karnofsky lecture; Brugge–Science of Oncology lecture; Wolmark–Gianni Bonadonna lecture

In Brief

Conversation with The Cancer Letter

TMIST PI Pisano: “Are we further reducing breast cancer mortality the more intensively we screen?”

Clinical Roundup

Drugs & Targets

Trump’s proposal for pediatric cancer has NCI envisioning the first data federation of its kind

Conversation with The Cancer Letter

Sharpless: With $500 million, NCI can create data federation that would change research in childhood cancer

Conversation with The Cancer Letter

CHOP’s Resnick: Big data will transition from research to the standard of care in the clinic

Conversation with The Cancer Letter

St. Jude’s Roberts: “No single institution can maximize cures and minimize toxicities alone”

Guest Editorial

Needed: A fully funded data federation for pediatric cancer with deep genomic sequencing and clinical records

Gottlieb resigns at FDA, recommends Sharpless as successor

In Brief

Funding Opportunities

FDA Oncology Center of Excellence publishes research contract opportunities

Clinical Roundup

Drugs & Targets

NCI Trials

NCI Trials for March

ODAC gives thumbs down to single-arm trial of two-drug combination for multiple myeloma

Committee focuses on meaning of equipoise, accelerated approval, confirmatory trials

FDA tightens regulation of robotic devices in minimally invasive surgery for cancer

In Brief

Conversation with The Cancer Letter

CDC: HPV vaccine dramatically reduced HPV-related cervical precancers over 6 years

Clinical Roundup

Drugs & Targets