Bristol Myers’ (BMY) Opdivo sBLA Gets FDA’s Priority Review
Bristol Myers Squibb BMY announced that the FDA has accepted its supplemental biologics license application (sBLA) for Opdivo (nivolumab) in combination with cisplatin-based chemotherapy as a first-line treatment for adult patients with unresectable or metastatic urothelial carcinoma under priority review.
The regulatory body is expected to deliver its final decision on Apr 5, 2024.
The sBLA was based on positive results from the phase III CHeckMate-901 study of the Opdivo/cisplatin combination regimen. Treatment with the combo therapy observed statistically significant and clinically meaningful survival benefits over standard-of-care gemcitabine plus cisplatin in the first-line treatment of adult patients with unresectable or metastatic urothelial carcinoma.
Per an assessment by an independent review body, the treatment of this patient population with the combo therapy followed by treatment with Opdivo monotherapy demonstrated statistically significant and clinically meaningful improvements in the primary efficacy endpoints of overall survival (OS) and progression-free survival.
The safety profile of the combo therapy was also found to be overall well tolerated and consistent with the known safety profiles of the individual components of the regimen. During the late-stage study, no new safety concerns were reported.
Year to date, shares of BMY have plunged 30.2% compared with the industry’s 20.7% decline.
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Bristol Myers’ phase III CheckMate -901 is also evaluating the efficacy of the Opdivo/Yervoy (ipilimumab) combo followed by Opdivo monotherapy compared with standard-of-care chemotherapy alone, in patients with untreated, unresectable or metastatic urothelial cancer. The late-stage study is ongoing to assess the clinical benefit of the Opdivo/Yervoy combo over standard-of-care chemotherapy.
Opdivo, the company’s PD-1 immune checkpoint inhibitor, was initially approved in 2014 to intravenously treat patients with unresectable or metastatic melanoma and disease progression following treatment with Yervoy. Currently, Opdivo is approved both as a monotherapy and in combination with Yervoy to treat a plethora of cancer indications in many countries, including the United States and EU.
Bristol Myers is also currently evaluating Opdivo in different clinical studies spread across all phases in a variety of tumor types.
Bladder cancer is one of the most common manifestations of cancer in the world, with more than 573,000 new cases diagnosed annually. The onset of urothelial carcinoma is most frequently observed in the cells that line the inside of the bladder and accounts for about 90% of bladder cancer cases. Apart from the bladder, urothelial carcinoma can also occur in other parts of the urinary tract.
Notably, in the recent past, the FDA expanded Opdivo’s adjuvant indication to include the adjuvant treatment of adult and pediatric patients aged 12 years and older with completely resected stage IIB or IIC melanoma. The approval was based on the results of the phase III CheckMate-76K study, wherein Opdivo demonstrated a statistically significant improvement in recurrence-free survival compared with placebo.
The drug was previously approved by the FDA for the adjuvant treatment of adult and pediatric patients aged 12 years and older with melanoma with involvement of lymph nodes or metastatic disease who have undergone complete resection.
Bristol Myers’ Opdivo has been driving growth for the company after receiving approval for several cancer indications. Total worldwide Opdivo sales were recorded at $6.6 billion for the first nine months ended Sep 30, 2023.
Bristol Myers Squibb Company Price and Consensus
Bristol Myers Squibb Company price-consensus-chart | Bristol Myers Squibb Company Quote
Zacks Rank and Stocks to Consider
Bristol Myers currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks worth mentioning are Puma Biotechnology, Inc. PBYI, ADMA Biologics ADMA and Agenus AGEN. While PBYI sports a Zacks Rank #1 (Strong Buy), ADMA and AGEN carry a Zacks Rank #2 (Buy) each at present. You can see the complete list of today’s Zacks #1 Rank stocks here.
In the past 30 days, the Zacks Consensus Estimate for Puma Biotech’s 2023 earnings per share has remained constant at 72 cents. During the same time frame, the estimate for Puma Biotech’s 2024 earnings per share has increased from 62 cents to 64 cents. Year to date, shares of PBYI have lost 12.1%.
PBYI’s earnings beat estimates in three of the last four quarters while missing on one occasion, delivering a four-quarter average earnings surprise of 76.55%.
In the past 30 days, the Zacks Consensus Estimate for ADMA Biologics’ 2023 loss per share has narrowed from 6 cents to 3 cents. The estimate for ADMA Biologics’ 2024 earnings per share is pegged at 16 cents. Year to date, shares of ADMA have gained 0.5%.
ADMA beat estimates in three of the trailing four quarters and matched in one, delivering an average earnings surprise of 63.57%.
In the past 30 days, the Zacks Consensus Estimate for Agenus’ 2023 loss per share has narrowed from 77 cents to 63 cents. During the same time frame, the estimate for Agenus’ 2024 loss per share has narrowed from 70 cents to 45 cents. Year to date, shares of AGEN have plunged 48.8%.
AGEN beat estimates in one of the trailing four quarters, matching in one and missing the mark on the other two occasions, delivering an average earnings surprise of 0.49%.
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Bristol Myers Squibb Company (BMY) : Free Stock Analysis Report
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Original: Investing Feed: Bristol Myers’ (BMY) Opdivo sBLA Gets FDA’s Priority Review