Bristol Myers Squibb Faces Potential Withdrawal of Opdivo's U.S. Indication for Hepatocellular Carcinoma

March 16, 2021 /Bio ValleyBIOON/ -- Bristol-Myers Squibb (BMS) recently announced that the U.S. Food and Drug Administration (FDA) will hold a public meeting of the Oncologic Drugs Advisory Committee (ODAC) from April 27 to 29, 2021Meeting, as part of the agency's industry-wide review, discussionTumorAccelerated Approval for the Drug. On April 29, Bristol-Myers Squibb will meet with the committee to discuss the indication for Opdivo (nivolumab) monotherapy in the treatment of hepatocellular carcinoma (HCC).

Ian M. Waxman, M.D., Head of Gastrointestinal Cancer Development at Bristol-Myers Squibb, stated: “We support the FDA’s efforts to evaluate accelerated approvals across the industry, which isFDAA Key Factor in Ensuring the Integrity of the Accelerated Approval Program. In PrimaryLiver CancerIn China, although the treatment landscape has changed over the past few years, we believe Opdivo continues to address unmet medical needs in the patient population following sorafenib treatment, and we appreciate the opportunity for further discussion with the Committee.”

2017, United StatesFDAAccelerated approval of Opdivo as a monotherapy for the treatment of patients with hepatocellular carcinoma (HCC) who have previously been treated with sorafenib. This accelerated approval is based on the Phase 1/2 CheckMate-040 trialTumorEfficacy Data. CheckMate-459 was a subsequent confirmatory randomized study comparing Opdivo with sorafenib in the first-line setting. According to the prespecified analysis, the primary endpoint of overall survival (OS) did not reach statistical significance.

Opdivo belongs to the class of PD-(L)1 cancer immunotherapies, which aim to harness the body’s own immune system to fight cancer by blocking the PD-1/PD-L1 signaling pathway, thereby inducing cancer cell death, and are effective in treating multiple typesTumorpotential. Currently, Opdivo has become a foundational therapy for multiple types of cancer.

Notably, as of now,Multiple anti-PD-(L)1 therapies have voluntarily withdrawn their accelerated approval indications in the United States.

On March 8, Roche voluntarily withdrew the U.S. indication for its anti-PD-L1 therapy Tecentriq (generic name: atezolizumab) for the treatment of patients with metastatic urothelial carcinoma (mUC, bladder cancer) who had previously received platinum-based chemotherapy.

On March 1, Merck voluntarily withdrew the indication for the anti-PD-1 therapy Keytruda (brand name: Keytruda; generic name: pembrolizumab) for the treatment of patients with metastatic small cell lung cancer (SCLC) who experienced disease progression during or after platinum-based chemotherapy and at least one other prior line of therapy.

February 22,AstraZenecaVoluntarily withdrew the U.S. indication for the anti-PD-L1 therapy Imfinzi (brand name: Imfinzi; generic name: durvalumab) for the treatment of patients with metastatic urothelial carcinoma (mUC, bladder cancer) who had previously received platinum-based chemotherapy.

All of the above decisions were made in collaboration with the United StatesFDAmade after consultation and as part of an industry-wide review of accelerated approvals granted for confirmatory trials that failed to meet their primary endpoints and had not yet received regular approval. (Bioon.com)

Original Source: Bristol Myers Squibb Statement on Opdivo® (nivolumab) Hepatocellular Carcinoma U.S. Indication