mRNA vaccine for melanoma is hailed as a turning point in medicine The data from Moderna and Merck’s trial have yet to be presented

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

Clinical Roundup

Intismeran cancer vaccine + Keytruda sustains 49% melanoma reduction after five years

A combination of a cancer vaccine and a drug, both of which harness the immune system to attack cancer cells, has proven successful in cutting the risk of skin cancer recurrence and death by 49%, according to a study led by researchers at NYU Langone Health and its Perlmutter Cancer Center.

May 22, 2026

Vol.52 No.20

Podcast

Reforms pending at USPSTF, plus, FDA rejects promising melanoma drug for the second time

The Cancer Letter’s coverage of HHS-led overhauls of foundational scientific institutions continued last week with two unrelated stories pointing to continued disarray amongst public health leadership.

May 06, 2026

mRNA vaccine for melanoma is hailed as a turning point in medicine

The data from Moderna and Merck’s trial have yet to be presented

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 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

Intismeran cancer vaccine + Keytruda sustains 49% melanoma reduction after five years

Reforms pending at USPSTF, plus, FDA rejects promising melanoma drug for the second time

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mRNA vaccine for melanoma is hailed as a turning point in medicine

The data from Moderna and Merck’s trial have yet to be presented

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

Intismeran cancer vaccine + Keytruda sustains 49% melanoma reduction after five years

Reforms pending at USPSTF, plus, FDA rejects promising melanoma drug for the second time

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