Vol.

No.

July 20, 2018Jul 20, 2018

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Cover Story

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”
from completion of trial to ODAC presentation

By Paul Goldberg

FDA spells out rules for new endpoint: Metastasis-free survival

By Paul Goldberg

Conversation with The Cancer Letter

Julia Beaver: SPARTAN and PROSPER showed MFS improvements greater than 20 months

By Paul Goldberg

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

By Paul Goldberg

Free Obituary

Marlene McCarthy, formidable Breast Cancer Coalition advocate, dies at 74

By Frances M. Visco

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

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

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Recent Issues

Volume 51 | Issue 46 - December 19, 2025

Pilot programs aim to revamp cancer drug approval process—

Novartis's Hirawat: “It's a continuous dialogue that goes on on a daily basis”
from completion of trial to ODAC presentation

FDA spells out rules for new endpoint: Metastasis-free survival

Julia Beaver: SPARTAN and PROSPER showed MFS improvements greater than 20 months

Maha Hussain: OS isn't a practical endpoint in the context where patients are likely to live 10 years or more

Marlene McCarthy, formidable Breast Cancer Coalition advocate, dies at 74

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

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

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