Jazz Hits High Note With Updated Zanidatamab Data In Biliary Tract Cancer At ASCO

Jun 04 2023

• By Alaric DeArment

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The company said it is in talks with the US FDA for an accelerated approval filing of the HER2-directed bispecific antibody, which showed better ORR and PFS than the standard of care.

Cancer

Jazz Pharmaceuticals plc has its eyes on becoming the first to receive US Food and Drug Administration approval for an agent in HER2-positive biliary tract cancer (BTC), with updated data at the American Society of Clinical Oncology (ASCO) annual meeting showing an extension of progression-free survival (PFS) among patients with the rare disease who received its HER2-directed bispecific antibody, zanidatamab.

The company presented updated safety and efficacy data from the 87-patient HERIZON-BTC-01 trial in an oral presentation at the meeting...

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