Bristol Myers Squibb BMY 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.