FDA grants Fast Track designation to Alpha1H for non-muscle invasive bladder cancer

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

FDA approves Pluvicto for mHSPC

FDA approved Pluvicto (lutetium Lu 177 vipivotide tetraxetan) in combination with an androgen receptor pathway inhibitor for patients with prostate-specific membrane antigen-positive metastatic androgen pathway modulation-naive/sensitive prostate cancer, commonly known as metastatic hormone-sensitive prostate cancer.

August 07, 2026

Vol.52 No.31

Podcast

Pour a Scotch, we’re talking clinical trials and prediction markets

In last week’s issue of The Cancer Letter, the cover story featured coverage of Kalshi, an online prediction market exchange, launching a pilot program in which one can place bets on both outcomes of trials and FDA decisions.

August 05, 2026

Cancer Policy

FDA’s OCE publishes three final guidances to increase clinical trial enrollment

FDA’s Oncology Center of Excellence has published three final guidance documents intended to broaden eligibility criteria for participation in clinical trials of oncology drugs.

Enfortumab vedotin + pembrolizumab improves survival and reduces recurrence risk in muscle-invasive bladder cancer, phase III trial finds

Researchers have found that a combination of enfortumab vedotin and pembrolizumab helps patients with muscle-invasive bladder cancer live longer while reducing the risk that their cancer will return after surgery, according to the results of an international phase III clinical trial.

July 31, 2026

Vol.52 No.30

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

FDA grants Fast Track designation to Alpha1H for non-muscle invasive bladder cancer

YOU MAY BE INTERESTED IN

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 approves Pluvicto for mHSPC

Pour a Scotch, we’re talking clinical trials and prediction markets

FDA’s OCE publishes three final guidances to increase clinical trial enrollment

Enfortumab vedotin + pembrolizumab improves survival and reduces recurrence risk in muscle-invasive bladder cancer, phase III trial finds

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

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FDA grants Fast Track designation to Alpha1H for non-muscle invasive bladder cancer

YOU MAY BE INTERESTED IN

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

FDA approves Pluvicto for mHSPC

Pour a Scotch, we’re talking clinical trials and prediction markets

FDA’s OCE publishes three final guidances to increase clinical trial enrollment

Enfortumab vedotin + pembrolizumab improves survival and reduces recurrence risk in muscle-invasive bladder cancer, phase III trial finds

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

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