Alembic Pharma Gets USFDA Nod for Generic Cancer Drug
Alembic Pharmaceuticals Ltd announced that it has received tentative approval from the United States health regulator for its generic version of the cancer treatment drug Binimetinib tablets.
In a regulatory filing, the company said the US Food and Drug Administration (USFDA) has granted tentative approval for its Abbreviated New Drug Application (ANDA) for Binimetinib tablets in the 45 mg strength.
According to the USFDA Paragraph IV certification list, Alembic is the first applicant for this product, having submitted its ANDA for Binimetinib Tablets 45 mg.
If the application receives final approval, the company may be eligible for 180 days of marketing exclusivity in the United States generic market.
The company had earlier received provisional approval for Binimetinib Tablets 15 mg, it added.
Binimetinib, used in combination with encorafenib, is indicated for the treatment of patients with unresectable or metastatic melanoma resistant to certain targeted cancer therapies.
It is also indicated, along with encorafenib, for adult patients with metastatic non-small cell lung cancer who have resistance to targeted therapies.
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According to IQVIA data cited by the company, the Binimetinib tablets market is estimated at about $259 million for the year ending March 2026.
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The tentative approval strengthens Alembic’s position in the US generics oncology segment and reflects its continued focus on complex oncology molecules.
The company said it will continue to work with the regulator toward final approval and subsequent commercial launch if all conditions are met.
Binimetinib is a MEK inhibitor used in targeted cancer therapy regimens and is typically administered in combination therapies to improve clinical outcomes in specific oncology indications.
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Alembic continues to expand its global portfolio of complex generics, focusing on regulated markets such as the United States and Europe to drive sustainable growth over the long term.