logo
Plus   Neg
Share
Email

Pfizer Says FDA Accepts SNDA For XALKORI, Grants Priority Review - Quick Facts

Pharma major Pfizer Inc. (PFE) announced Wednesday that the U.S. Food and Drug Administration (FDA) has accepted and granted priority review to its supplemental New Drug Application(sNDA)for XALKORI (crizotinib) for the treatment of pediatric patients with relapsed or refractory systemic anaplastic large cell lymphoma (ALCL) that is anaplastic lymphoma kinase (ALK)-positive.

XALKORI received Breakthrough Therapy designation (BTD) for the ALK-positive ALCL indication in May 2018 and if approved, would be the first biomarker-driven therapy for this type of pediatric lymphoma. The Prescription Drug User Fee Act (PDUFA) goal date for a decision by the FDA is January 2021.

The FDA submission is supported by the results from Study ADVL0912 (NCT00939770) and Study A8081013 (NCT01121588). Study ADVL0912 is a Phase 1/2 study conducted in collaboration with the Children's Oncology Group (COG).

Anaplastic large cell lymphoma is a rare type of non-Hodgkin lymphoma (NHL), divided into ALK-positive or ALK-negative disease.

XALKORI is a tyrosine kinase inhibitor (TKI) indicated for the treatment of patients with metastatic NSCLC whose tumors are ALK-positive or ROS1-positive as detected by an FDA-approved test.

For comments and feedback contact: editorial@rttnews.com

Business News

Editors Pick
Procter & Gamble's skincare brand Olay will debut its first float in the 94th Annual Macy's Thanksgiving Day Parade to be held on November 26 this year. To highlight the low representation of women in the STEM or science, technology, engineering, and math jobs, Olay said that its Thanksgiving Day Parade float will feature a 'Women in STEM' theme. Alternative meat producer Impossible Foods is debuting its flagship product this week in Asian grocery stores. The plant-based meat products will go on sale at about 200 grocery stores in Hong Kong and Singapore, its first grocery foray outside the U.S. Impossible Beef was the flagship product which made its worldwide grocery store debut in 2019. Ahead of the upcoming holiday season, Lowe's Companies Inc. is launching competitive deals urging customers to "gift back" to their home, the place that has meant so much this year amid the coronavirus pandemic. The home improvement retailer is introducing a new Season of Savings, beginning earlier than ever on October 22.
Follow RTT