Bristol Myers Squibb ( BMY Quick Quote BMY - Free Report) announced that the European Medicines Agency (“EMA”) has validated its type II variation application for Opdivo (nivolumab) in combination with chemotherapy.
The application sought approval for the neoadjuvant treatment of patients with resectable stage IB to IIIA non-small cell lung cancer (NSCLC).
Consequently, the EMA has begun its centralized review procedure as the validation confirms the submission is complete.
A tentative approval will make this Opdivo regimen the first and only immunotherapy-based option authorized for use before surgery in NSCLC patients in the European Union.
The application is based on the phase III CheckMate -816 study data. The data from the study showed that three cycles of Opdivo in combination with chemotherapy demonstrated a statistically significant and clinically meaningful improvement in event-free survival (EFS) and pathologic complete response (pCR) versus chemotherapy alone when given before surgery.
The FDA also approved Opdivo in combination with chemotherapy for the treatment of adult patients with resectable (tumors ≥4 cm or node positive) NSCLC in the neoadjuvant setting based on results from the CheckMate -816 study.
Opdivo-based therapies have shown improved efficacy in the neoadjuvant or adjuvant treatment of four tumor types: NSCLC, bladder cancer, esophageal/gastroesophageal junction cancer and melanoma.
Bristol Myers and its partners are evaluating the use of adjuvant and peri-operative immunotherapy, as well as immunotherapy in association with chemoradiation, in non-metastatic NSCLC.
The performance of immuno-oncology drug Opdivo, approved for multiple cancer indications, revived after a slowdown early in 2021. Opdivo is one of the top revenue generators for BMY, and the continued label expansion of the drug for additional indications should further boost its growth potential.
Sales of the drug came in at $7.5 billion in 2021, up 8% from 2020.
Shares of Bristol Myers have rallied 16.6% year to date against the
industry’s decline of 13.3%.
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The solid performance of key drugs, namely Revlimid and Eliquis, along with Opdivo maintains momentum for BMY and should fuel growth. The company is also focusing on diversifying its revenue base. The approval of new drugs in recent times adds a revenue stream, which should boost growth in the coming quarters. In 2021, Bristol Myers obtained 20 approvals for new drugs and label expansions of existing drugs in major markets, including regulatory approvals of Breyanzi and Abecma in hematology malignancies.
However, competition is stiff for Opdivo from the likes of
Merck’s ( MRK Quick Quote MRK - Free Report) blockbuster drug Keytruda. Keytruda, approved for various oncology indications, is the key driver for MRK.
Continued label expansions of the drug have boosted Merck’s top line.
Bristol-Myers currently carries a Zacks Rank #3 (Hold). A few better-ranked stocks in the biotech sector are
Vertex Pharmaceuticals ( VRTX Quick Quote VRTX - Free Report) and Kaleido Biosciences , both carrying a Zacks Rank #2 (Buy) at present. You can see . the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here
The consensus estimate for Vertex’s 2022 earnings has increased $1.13 over the past 60 days to $14.52. Shares of VRTX have gained 16.4% in the year to date.
Loss estimates for KLDO have narrowed to $1.64 from $2.13 for 2022 in the past 60 days. Earnings of Kaleido Biosciences surpassed estimates in three of the trailing four quarters and missed the same once.