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Xalkori set for rapid review in new lung cancer indication

Pfizer could produce first FDA-approved biomarker-driven therapy for ROS1-positive NSCLC

Pfizer Xalkori 

Pfizer's fast-growing lung cancer therapy Xalkori could be approved for broader use in the US by next April, after the FDA granted a priority review for a new indication.

Xalkori (crizotinib) is already used to treat patients with metastatic non-small cell lung cancer (NSCLC) whose tumours test positive for ALK mutations, and is now under review for patients with ROS1-positive NSCLC.

ROS1 mutations are seen in round 1% of the 1.5m new cases of NSCLC diagnosed each year around the world, and share common features with ALK mutations even though they are rarely encountered in the same tumour.

Xalkori has ALK, ROS1 and MET inhibitor properties, and has been approved as a second-line therapy for ALK-positive VSCLC since 2012. In a phase I trial involving 50 ROS1-positive NSCLC patients, Xalkori was found to achieve an overall response rate of 72%, with three complete responses and 33 partial responses.

The level of response is much higher than that seen with conventional chemotherapy, even though ROS1-positive NSCLC seems to be fairly sensitive to Eli Lilly's Alimta (pemetrexed).

If Pfizer's marketing application is successful, Xalkori would be the first FDA-approved biomarker-driven therapy for the treatment of ROS1-positive metastatic NSCLC, Pfizer said, which has also been awarded breakthrough status for Xalkori in this indication.

Despite affecting only around 15,000 patients a year, ROS1-posotove NSCLC typically requires a long duration of treatment, so the new indication could lend additional momentum to Xalkori's sales growth.

Xalkori is one of Pfizer's fastest-growing new products, with sales rising 23% to $353m in the first nine months of the year. In addition to the possible contribution from ROs1-positive NSCLC, Pfizer has just secured approval in Europe for the drug as a first-line therapy for ALK-positive NSCLC.

Pfizer's drug - which was recently partnered with Merck KGaA - was the only ALK inhibitor on the market until earlier this year when it was joined by Novartis' Zykadia (ceritinib), which is approved for use in patients previously treated with Xalkori.

Article by
Phil Taylor

10th December 2015

From: Research

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