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Poll
POLL: Which Skin Cancer Drug Recently Received a Complete Response Letter From the FDA?
Author(s):
Key Takeaways
- Moderna and Merck's mRNA-4157 with pembrolizumab reduces distant metastasis or death risk by 62% in high-risk melanoma patients.
- AiViva Biopharma's AIV001 shows promise as a non-surgical treatment for basal cell carcinoma, with a novel mechanism of action.
Click here to answer this week's poll about a recent FDA Complete Response Letter.
Which skin cancer drug recently received a Complete Response Letter from the FDA?
All 3 drugs listed in this poll have recently made appearances in the news for various reasons.
Moderna and Merck recently announced follow-up data from the phase 2b randomized KEYNOTE-942/mRNA-4157-P201 study, a clinical trial evaluating mRNA-4157 (V940), an investigational individualized neoantigen therapy, in combination with pembrolizumab (Keytruda), Merck's anti-PD-1 therapy, in patients with resected high-risk melanoma (stage III/IV) following complete resection.
V940 plus pembrolizumab also continued to demonstrate a meaningful improvement in distant metastasis-free survival, compared with pembrolizumab alone, reducing the risk of developing distant metastasis or death by 62%.
Read more from Dermatology Times here.
Additionally, AiViva Biopharma recently announced positive and promising data from its phase 1/2 clinical trial of AIV001 (Axitinib), a novel intradermal treatment, in patients with basal cell carcinoma.
“It is exciting and important to have AiViva Biopharma develop a drug, with a new mechanism of action, that has the potential to treat BCC that avoids surgery,” said Brian Berman, MD, PhD, in a press release. Berman is Professor Emeritus of Dermatology and Dermatologic Surgery at The University of Miami Miller School of Medicine.
Read more from Dermatology Times here.
Checkpoint Therapeutics, Inc. faces a delay in the approval process for its cosibelimab biologic license application (BLA) following the issuance of a complete response letter (CRL) by the US Food and Drug Administration (FDA).
The CRL specifically points to issues uncovered during an FDA inspection of Checkpoint's third-party contract manufacturing organization.
Notably, no concerns were raised regarding clinical data, safety, or labeling.
James Oliviero, President and CEO of Checkpoint, remains optimistic, stating that the company aims to address the deficiencies in a resubmission, anticipating marketing approval for cosibelimab in 2024.
Reference
U.S. Food and Drug Administration Issues Complete Response Letter for COSIBELIMAB solely due to inspection findings at third-party manufacturer. Checkpoint Therapeutics, Inc. December 18, 2023. Accessed December 19, 2023. https://ir.checkpointtx.com/news-events/press-releases/detail/111/u-s-food-and-drug-administration-issues-complete-response
