Regulatory Daily Summary
Regulatory Daily Summary: What Happened on October 13, 2026
China approves Foresee’s Camcevi for advanced prostate cancer
Reports link Neurocrine’s Vykat XR to seven deaths and nearly 100 hospitalizations, but do not establish that the drug caused them.
Today in brief
China approved Foresee Pharmaceuticals’ Camcevi 42 mg for adults with advanced prostate cancer.1 Patient advocates and experts raised concerns about Vykat XR after reports linked the Prader-Willi syndrome drug to seven deaths and nearly 100 hospitalizations, without establishing causation.2
China clears Foresee’s Camcevi 42 mg
China’s National Medical Products Administration approved Camcevi 42 mg for adults with advanced prostate cancer, Foresee Pharmaceuticals said it learned from its Chinese licensing partner, GenSci.1 The drug is a ready-to-administer, six-month depot injection of leuprolide mesylate under the skin.1
GenSci holds exclusive commercial rights in China for Camcevi across current and developing indications, including central precocious puberty and premenopausal breast cancer.1 Foresee chief executive Ben Chien said GenSci’s planned China launch would support growth of the global Camcevi business.1
The 42 mg formulation is also approved for advanced prostate cancer in Canada, the European Union, Israel, Taiwan, the United Kingdom and the United States.1 US sales began in April 2022.1
Vykat XR safety reports include seven deaths
Reports submitted to regulators have linked Neurocrine Biosciences’ Vykat XR to seven deaths and nearly 100 hospitalizations since its approval for Prader-Willi syndrome.2 The reports do not establish that Vykat XR caused the events.2
Patient advocates and some experts have become increasingly concerned about the drug’s perceived risks.2 Some experts argue that the evidence is enough to conclude Vykat XR is causing unacceptable harm.2 An open letter about potential safety issues was released two months ago. Vykat XR was approved 18 months ago.2