Adjuvant Keytruda provides higher QoL than standard of care immunotherapy in melanoma

ODAC votes decisively in support of PD-L1 expression as predictive biomarker for checkpoint inhibitors
Vote may lead to rollback of some indications held by BMS and Merck

The FDA Oncologic Drugs Advisory Committee on Sept. 26 voted that PD-L1 inhibitors should not be indicated as a first-line treatment for patients with PD-L1-negative gastric/gastroesophageal junction adenocarcinoma and esophageal squamous cell carcinoma.

Vanderbilt receives $1M grant to fund immunotherapy research in CRC

The Robert J. Kleberg Jr. and Helen C. Kleberg Foundation awarded a $1 million grant to support research at Vanderbilt aimed at dramatically expanding the efficacy of immunotherapy for colorectal cancer.

October 04, 2024

Vol.50 No.37

Regulatory News

ODAC votes overwhelmingly in support of PD-L1 expression as predictive biomarker for efficacy of checkpoint inhibitors
Vote applies across drugs and indications

The FDA Oncologic Drugs Advisory Committee on Sept. 26 voted that PD-L1 inhibitors should not be indicated for patients with PD-L1-negative gastric/gastroesophageal junction adenocarcinoma and esophageal squamous cell carcinoma.

Roger Lo awarded $2M NIH grant to study melanoma treatment resistance

Roger Lo, professor of medicine, dermatology, and molecular and medical pharmacology and investigator at the UCLA Health Jonsson Comprehensive Cancer Center, was awarded a $2 million grant from NIH to investigate innovative strategies to prevent drug resistance in melanoma treatment and improve the effectiveness of MAPK inhibitors, a common treatment for patients with melanomas that carry the BRAFV600 mutation.

September 27, 2024

Vol.50 No.36

Drugs & Targets

EU CHMP gives positive opinion to Keytruda for two types of gynecologic cancers

The European Medicines Agency’s Committee for Medicinal Products for Human Use adopted positive opinions recommending approval of Keytruda (pembrolizumab), an anti-PD-1 therapy, for two indications in gynecologic cancers.

September 27, 2024

Vol.50 No.36

Regulatory News

Melanoma investigators invite FDA to publicly discuss approval endpoints and crossover design
The agency accepts the invitation

A group of melanoma experts, joined by three advocacy groups focused on melanoma, has engaged FDA in a public discussion of the challenges of developing new drugs in the refractory setting and the role crossover can play in such trials.

September 20, 2024

Vol.50 No.35

By Paul Goldberg

Adjuvant Keytruda provides higher QoL than standard of care immunotherapy in melanoma

YOU MAY BE INTERESTED IN

ODAC votes decisively in support of PD-L1 expression as predictive biomarker for checkpoint inhibitors
Vote may lead to rollback of some indications held by BMS and Merck

Vanderbilt receives $1M grant to fund immunotherapy research in CRC

ODAC votes overwhelmingly in support of PD-L1 expression as predictive biomarker for efficacy of checkpoint inhibitors
Vote applies across drugs and indications

Roger Lo awarded $2M NIH grant to study melanoma treatment resistance

EU CHMP gives positive opinion to Keytruda for two types of gynecologic cancers

Melanoma investigators invite FDA to publicly discuss approval endpoints and crossover design
The agency accepts the invitation

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Adjuvant Keytruda provides higher QoL than standard of care immunotherapy in melanoma

YOU MAY BE INTERESTED IN

ODAC votes decisively in support of PD-L1 expression as predictive biomarker for checkpoint inhibitorsVote may lead to rollback of some indications held by BMS and Merck

Vanderbilt receives $1M grant to fund immunotherapy research in CRC

ODAC votes overwhelmingly in support of PD-L1 expression as predictive biomarker for efficacy of checkpoint inhibitorsVote applies across drugs and indications

Roger Lo awarded $2M NIH grant to study melanoma treatment resistance

EU CHMP gives positive opinion to Keytruda for two types of gynecologic cancers

Melanoma investigators invite FDA to publicly discuss approval endpoints and crossover designThe agency accepts the invitation

Can you spare 10 minutes to complete a survey?

Login

ODAC votes decisively in support of PD-L1 expression as predictive biomarker for checkpoint inhibitors
Vote may lead to rollback of some indications held by BMS and Merck

ODAC votes overwhelmingly in support of PD-L1 expression as predictive biomarker for efficacy of checkpoint inhibitors
Vote applies across drugs and indications

Melanoma investigators invite FDA to publicly discuss approval endpoints and crossover design
The agency accepts the invitation