Pfizer's Xalkori picks up FDA nod for rare ALK-positive tumors

First endorsed 11 years ago for anaplastic lymphoma kinase (ALK)-positive lung cancer, Pfizer’s Xalkori is being surpassed in that indication by the company’s own Lorbrena and Takeda’s Alunbrig.

But Xalkori is still garnering approvals for other ALK-positive disorders. On Thursday, Xalkori got its second nod in as many years. The kinase inhibitor was blessed to treat unresectable, recurrent or refractory inflammatory ALK-positive myofibroblastic tumors.

The approval is for patients with tumors that can't be removed by surgery and are progressing despite prior treatment.

This green light comes 18 months after Xalkori won approval for a rare form of non-Hodgkin lymphoma—relapsed or refractory anaplastic large cell lymphoma (ALCL) that is ALK-positive.

The FDA based its most recent approval on two single-arm, open-label trials. Of 14 pediatric patients, 12 achieved a tumor shrinkage, while five of seven adults did the same.

ALK-positive disorders are genetic and can strike at an early age. For example, while only 5% of lung cancer patients are ALK-positive, 30% of those under age 40 with lung cancer are ALK-positive.

While Pfizer reported sales of Lorbrena at $266 million last year, a 30% increase from 2020, sales of Xalkori dipped to $493 million, a 9% decrease. Xalkori’s sales peaked in 2017 at $594 million.

Lorbrena was originally approved in 2018 for previously-treated ALK-positive NSCLC. Then in March of last year, it won a first-line nod in ALK-positive metastatic lung cancer.