AstraZeneca and MSD Report FDA’s Acceptance of NDA for Selumetinib in Patients with Neurofibromatosis Type 1

 AstraZeneca and MSD Report FDA’s Acceptance of NDA for Selumetinib in Patients with Neurofibromatosis Type 1

AstraZeneca and MSD Report FDA’s Acceptance of NDA for Selumetinib in Patients with Neurofibromatosis Type 1

Shots:

  • The US FDA has accepted NDA and granted Priority Review for Selumetinib as a new therapy for pediatric patients aged ≥3yrs. with neurofibromatosis type 1 (NF1) and symptomatic, inoperable plexiform neurofibromas (PNs)
  • The NDA submission is based on SPRINT P-II Stratum 1 study evaluating Selumetinib (bid, PO) in pediatric patients with NF1 and symptomatic, inoperable PNs demonstrated 66% ORR which is defined as the percentage of patients with a confirmed complete or partial response of ≥ 20% tumor volume reduction
  • Selumetinib is a MEK 1/2 inhibitor, act by inhibiting MEK enzyme in the RAS/MAPK pathway which is associated with the growth & proliferation of cancer cells in multiple tumor types

Click here to­ read full press release/ article | Ref: AstraZeneca | Image: Investors Chronicle

Tuba Khan

Tuba Khan is Senior Editor at PharmaShots. She is curious, creative, and passionate about recent updates and innovation in the Life sciences industry. She covers Biopharma, MedTech, and Digital health segments. Tuba also has an experience of digital and social media marketing and runs the campaigns independently. She can be contacted on tuba@pharmashots.com

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