Bristol Myers Squibb (BMY Quick QuoteBMY ) announced that its blockbuster drug Opdivo (nivolumab), as an injection for intravenous use, has received approval from the FDA to treat adjuvant patients with urothelial carcinoma (“UC”) who are at high risk of recurrence after undergoing radical resection, regardless of prior neoadjuvant chemotherapy, nodal involvement or PD-L1 status.
Following approval, Opdivo is the first and only PD-1 inhibitor approved for urothelial carcinoma in the adjuvant setting. The FDA approval also marks the drug’s third indication in the adjuvant setting, following the approval for melanoma in 2017 and esophageal or gastroesophageal junction cancer in May 2021.
The label expansion for Opdivo was approved under the FDA’s Real-Time Oncology Review pilot program, which aims to ensure that safe and effective treatments are available to patients as early as possible.
The company’s stock has risen 11.6% so far this year against the industry’s decline of 1.9%.
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The FDA approval was based on data from the phase III CheckMate-274 study, which compared Opdivo with placebo as an adjuvant treatment in patients who underwent radical resection of UC originating in the bladder or upper urinary tract and were at high risk of recurrence. The study demonstrated that Opdivo reduced the risk of disease recurrence or death by 30% compared to placebo but nearly doubled the median disease-free survival.
Please note that Opdivo is already approved for multiple indications including melanoma, renal cell carcinoma, second-line non-small-cell lung cancer, classical Hodgkin lymphoma, and recurrent or metastatic squamous cell carcinoma of the head and neck.
UC is the most common type of bladder cancer in adults in the United States. In addition to the bladder, UC can occur in other parts of the urinary tract, including ureter and renal pelvis. Per the press release, 81,000 new cases of bladder cancer are diagnosed each year, out of which majority cases are UC.
Last week, Bristol Myers announced that the European Commission has granted Conditional Marketing Authorization to its chimeric antigen receptor T cell immunotherapy, Abecma, for the treatment of adult patients with relapsed and refractory multiple myeloma who have received at least three prior therapies — including an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 antibody — and have demonstrated disease progression on the last therapy.
In July, Seagen (SGEN Quick QuoteSGEN ) and partner Astellas’ Pacdev was approved by the FDA to treat patients with locally advanced or metastatic urothelial cancer who have been previously treated with a PD-1/L1 inhibitor and are not eligible for cisplatin.
Bristol Myers Squibb Company Price 
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Zacks Rank & Stocks to Consider
Bristol Myers currently carries a Zacks Rank #3 (Hold). A couple of better-ranked stocks in the biotech/drug sector are Horizon Therapeutics (HZNP Quick QuoteHZNP ) and Regeneron Pharmaceuticals (REGN Quick QuoteREGN ) , each sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Horizon’s earnings per share estimates for 2021 have increased from $3.62 to $4.46 in the past 30 days. The same for 2022 has risen from $5.18 to $5.84 over the same period. The stock has rallied 43.6% in the year so far.
Regeneron’s earnings per share estimates for 2021 have increased from $49.96 to $54.15 in the past 30 days. The same for 2022 has risen from $40.91 to $44.11 over the same period. The stock has rallied 37.3% in the year so far.
