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Biotech Stocks Facing FDA Decision In January 2021

Pfizer
Pfizer

Pfizer Inc. (PFE) has sought FDA approval for a new indication of Xalkori, with the decision expected in January 2021.

The proposed new indication is for the treatment of pediatric patients with relapsed or refractory systemic anaplastic large cell lymphoma (ALCL) that is anaplastic lymphoma kinase (ALK)-positive. If approved, Xalkori would be the first biomarker-driven therapy for this type of pediatric lymphoma.

Anaplastic large cell lymphoma is a rare type of non-Hodgkin lymphoma, divided into ALK-positive or ALK-negative disease.

Xalkori is already approved for the treatment of patients with metastatic non-small cell lung cancer whose tumors are ALK-positive or ROS1-positive as detected by an FDA-approved test.

Sales of Xalkori in the third quarter of 2020 were $122 million, down 6% from the comparable year-ago quarter.

PFE closed Monday’s (Dec.28, 2020) trading at $36.82, down 1.21%.