SWOG study shows neoadjuvant Keytruda helps prevent recurrence in high-risk melanoma

FDA approves companion diagnostic supporting patients with advanced melanoma

FDA approved Labcorp’s PGDx elio tissue complete CDx as a companion diagnostic to help identify patients with advanced melanoma with certain BRAF variants who may benefit from treatment with FDA-approved targeted therapies.

August 14, 2026

Vol.52 No.32

Podcast

What happened at FDA? Replimune approval raises questions

Last week, FDA granted accelerated approval to Replimune Group Inc. for it’s biologic, RP1 (vusolimogene oderparepvec), following the FDA Cellular, Tissue, and Gene Therapies Advisory Committee’s 10:3 vote in support of the biologic in combination with nivolumab for the treatment of advanced melanoma in patients who have progressed on prior anti-PD-1 therapy.

August 12, 2026

Regulatory News

FDA grants Replimune’s RP1 an accelerated approval on third submission after 10:3 vote from advisory committee
Amid political outcry, advisors accept weak data and give sponsor a chance to complete phase III trial

FDA has granted an accelerated approval to RP1 (vusolimogene oderparepvec) following the agency’s Cellular, Tissue, and Gene Therapies Advisory Committee’s 10:3 vote in support of the biologic in combination with nivolumab for the treatment of advanced melanoma in patients who have progressed on prior anti-PD-1 therapy.

August 07, 2026

Vol.52 No.31

By Jacquelyn Cobb and Paul Goldberg

Drugs & Targets

After two CRLs, FDA advisory committee votes in favor of Replimune’s melanoma drug

FDA’s Cellular, Tissue, and Gene Therapies Advisory Committee voted 10:3 in favor of Replimune’s Biologics License Application for RP1 (vusolimogene oderparepvec) in combination with nivolumab for the treatment of advanced melanoma.

July 31, 2026

Vol.52 No.30

Obituary

Maura Gillison, who identified the role of HPV in head and neck cancer, changing the standard of care, dies at 61

Maura L. Gillison, MD, PhD, a medical oncologist and molecular epidemiologist whose work changed the standard of care for head and neck cancer by distinguishing human papillomavirus-positive from HPV-negative disease and thereby guiding diagnosis, treatment and prevention, died on June 21.

MD Anderson’s Vincent Bernard receives Project Purple’s Research Recovery Grant for pancreatic cancer research

Project Purple has awarded a $375,000 Research Recovery Grant to researchers at the University of Texas MD Anderson Cancer Center to continue critical pancreatic cancer research.

June 26, 2026

Vol.52 No.25

SWOG study shows neoadjuvant Keytruda helps prevent recurrence in high-risk melanoma

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FDA approves companion diagnostic supporting patients with advanced melanoma

What happened at FDA? Replimune approval raises questions

FDA grants Replimune’s RP1 an accelerated approval on third submission after 10:3 vote from advisory committee
Amid political outcry, advisors accept weak data and give sponsor a chance to complete phase III trial

After two CRLs, FDA advisory committee votes in favor of Replimune’s melanoma drug

Maura Gillison, who identified the role of HPV in head and neck cancer, changing the standard of care, dies at 61

MD Anderson’s Vincent Bernard receives Project Purple’s Research Recovery Grant for pancreatic cancer research

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SWOG study shows neoadjuvant Keytruda helps prevent recurrence in high-risk melanoma

YOU MAY BE INTERESTED IN

FDA approves companion diagnostic supporting patients with advanced melanoma

What happened at FDA? Replimune approval raises questions

FDA grants Replimune’s RP1 an accelerated approval on third submission after 10:3 vote from advisory committeeAmid political outcry, advisors accept weak data and give sponsor a chance to complete phase III trial

After two CRLs, FDA advisory committee votes in favor of Replimune’s melanoma drug

Maura Gillison, who identified the role of HPV in head and neck cancer, changing the standard of care, dies at 61

MD Anderson’s Vincent Bernard receives Project Purple’s Research Recovery Grant for pancreatic cancer research

Never miss an issue!

Login

FDA grants Replimune’s RP1 an accelerated approval on third submission after 10:3 vote from advisory committee
Amid political outcry, advisors accept weak data and give sponsor a chance to complete phase III trial