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Part of situation: FDA priority reviews for new medical therapies (2 clusters)

FDA grants priority review to two new investigational therapies

FDA priority review elinzanetant efzimfotase alfa breast cancer hypophosphatasia

The FDA has granted priority review to two investigational therapies for specific medical conditions.

Bayer’s elinzanetant (Lynkuet) has received priority review via a Supplemental New Drug Application to treat vasomotor symptoms (VMS) in women undergoing endocrine therapy for hormone receptor-positive (HR+) breast cancer. This follows previous indications for menopause-associated VMS. The application is supported by results from the Phase III OASIS-4 trial.

Additionally, Alexion and AstraZeneca Rare Disease announced that the FDA granted priority review for efzimfotase alfa, an enzyme replacement therapy for hypophosphatasia (HPP) in patients aged 2 years and older. A decision on the biologics license application is expected in the first half of 2027. The therapy aims to address skeletal and functional manifestations of the rare metabolic disease with a subcutaneous administration schedule every two weeks.

Entities

Alexion · AstraZeneca · Bayer · FDA

Sources

FDA grants priority review to elinzanetant for VMS in women receiving endocrine therapy for breast cancer [www.contemporaryobgyn.net]
FDA grants priority review to leniolisib sNDA for lower-weight children with APDS [www.contemporarypediatrics.com]
Hot Flashes From Breast Cancer Treatment May Soon Have an FDA-Approved Fix | CURE [www.curetoday.com]
FDA Extends Relutrigine Review, Delays PDUFA to December | NeurologyLive - Clinical Neurology News and Neurology Expert Insights [www.neurologylive.com]