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Biotech Stocks Facing FDA Decision In October 2023

Bristol Myers Squibb
Bristol Myers Squibb

Bristol Myers Squibb (BMY) has sought FDA approval to expand the use of its blockbuster drug Opdivo as monotherapy in the adjuvant setting for the treatment of patients with completely resected stage IIB or IIC melanoma and the decision is due on October 13, 2023.

Opdivo is approved for various cancer types say, melanoma, malignant pleural mesothelioma, non-small cell lung cancer, renal cell carcinoma, and classical Hodgkin lymphoma, to name a few.

In the indication of melanoma, Opdivo, as a single agent, is approved for the treatment of patients with BRAF V600 mutation-positive unresectable or metastatic melanoma, for the treatment of patients with BRAF V600 wild-type unresectable or metastatic melanoma. In combination with Yervoy, Opdivo is approved for the treatment of patients with BRAF V600 wild-type unresectable or metastatic melanoma. As adjuvant therapy, the drug is approved for patients with completely resected melanoma with lymph node involvement or metastatic disease (stage IIIB/C or stage IV melanoma).

Opdivo generated global sales of $2.15 billion in the second quarter of 2023, an increase of 4% over the year-ago quarter.

BMY closed Wednesday’s trading at $56.16.