No more ac­cel­er­at­ed ap­provals for PI3K? Biotech cites FDA's 'cur­rent po­si­tion' as it warns of ma­jor de­lay

Did the FDA change its mind about the class of blood can­cer drugs known as PI3K?

Where­as the agency had pre­vi­ous­ly grant­ed ac­cel­er­at­ed ap­provals to PI3K drugs to treat hema­to­log­ic ma­lig­nan­cies, that op­tion is ap­par­ent­ly off the ta­ble for zan­delis­ib, a can­di­date from MEI Phar­ma and Ky­owa Kirin. For the com­pa­nies, that means de­lay­ing a po­ten­tial monother­a­py launch from 2023 to 2026, ac­cord­ing to an­a­lysts.

Unlock this article instantly by becoming a free subscriber.

You’ll get access to free articles each month, plus you can customize what newsletters get delivered to your inbox each week, including breaking news.

SIGN UP LOG IN BECOME A PREMIUM SUBSCRIBER