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Thursday, Jun 8, 2023

European Regulators Give an Early Nod to Cancer Treatments From Puma, Kite

European drug regulators have recommended the approval of two cancer treatments developed by two Los Angeles-area biotech companies – Puma Biotechnology Inc. of West L.A., and Kite, a Gilead Co., of Santa Monica.

A Committee for Medicinal Products for Human Use issued a positive opinion on June 28 recommending marketing approval for Puma’s Nerlynx therapy for HER2-positive early stage breast cancer, reversing a negative opinion issued in January requesting additional data.

The same European committee also issued a positive verdict on Kite’s personalized CAR-T immunotherapy for adults with non-Hodgkin’s lymphoma. The company leased a building in the Netherlands last month to produce its gene-based cancer therapies in Europe.

The CHMP recommendations will now be reviewed by the European Commission, which has the power to approve medicines for use in the 28 countries of the EU, plus Norway, Iceland and Liechtenstein.

Puma’s Nerlynx drug, designed to prevent an aggressive breast cancer after chemotherapy, was approved by the U.S. Food and Drug Administration in July 2017.

Kite’s Yescarta cell therapy was approved in October 2017, three months after Gilead Sciences Inc. of Foster purchased Kite Pharma Inc. for $11.9 billion.

Health business reporter Dana Bartholomew can be reached at dbartholomew@labusinessjournal.com. Follow him on Twitter @_DanaBart.

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