Category: ODD/BTA/FTA Status Region: North America · United States Company: Astrazeneca Lp

AstraZenecas selumetinib with breakthrough designation

AstraZenecas selumetinib with breakthrough designation
AstraZeneca and MSD have been collaborating for just under two years in oncology, and have so far enjoyed success in accelerating the progress of PARP inhibitor Lynparza. The tie-up is allowing both companies to bring more firepower to R&D and marketing of the drugs, including novel combination trials across their respective oncology portfolios. Today the spotlight has been turned on the other molecule in the co-development and co-commercialisation partnership, selumetinib, a MEK 1/2 inhibitor with potential across a range of targeted uses. The partners have just announced that the FDA has granted the two companies Breakthrough Therapy Designation (BTD) for selumetinib in a rare paediatric condition. The news is a welcome turn around for the molecule, which failed in a phase 3 trial in non-small cell lung cancer (NSCLC) back in 2016. Now the new niche setting could help AZ and MSD add another drug to their oncology armoury. There are several other MEK inhibitor drugs already on the market, including Novartis

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