Gary Schwartz named director at Case CCC

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

Drugs & Targets

FDA approves Tecelra for pediatric synovial sarcoma

FDA granted full approval of Tecelra (afamitresgene autoleucel) and expanded its indication to include pediatric patients 12 years of age and older with unresectable or metastatic synovial sarcoma who have received prior chemotherapy, are HLA-A*02:01P, -A*02:02P, -A*02:03P, or -A*02:06P positive and whose tumor expresses the MAGE-A4 antigen as determined by FDA-approved or cleared companion diagnostic devices.

June 26, 2026

Vol.52 No.25

Clinical Roundup

OST-HER2 achieves 2.5-year OS in fully resected pulmonary metastatic osteosarcoma, phase IIb trial finds

OST-HER2 (OST31-164) achieved statistically significant benefit for treated patients in overall survival at the 2.5-year timepoint in the prevention or delay of recurrence in fully resected, pulmonary metastatic osteosarcoma (75% vs. 47%, p = 0.003).

June 05, 2026

Vol.52 No.22

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

Gary Schwartz named director at Case CCC

YOU MAY BE INTERESTED IN

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

FDA approves Tecelra for pediatric synovial sarcoma

OST-HER2 achieves 2.5-year OS in fully resected pulmonary metastatic osteosarcoma, phase IIb trial finds

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

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Gary Schwartz named director at Case CCC

YOU MAY BE INTERESTED IN

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

FDA approves Tecelra for pediatric synovial sarcoma

OST-HER2 achieves 2.5-year OS in fully resected pulmonary metastatic osteosarcoma, phase IIb trial finds

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

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