Approval milestones – Hutchmed, SpringWorks, Crispr and Ionis eye firsts
A work-stretched US FDA has several key approval application still to review by the end of 2023.
12 years on, Jakafi faces serious JAK competition
Momelotinib gains full US approval in a broader setting than expected, validating GSK’s $1.9bn buyout of Sierra Oncology.
Bicycle aims to follow in Padcev’s slipstream
A study to back accelerated approval is to start next year, but the prospect of seeing a fully greenlit Padcev before then looms large.
Tivdak success could make life even harder for Iovance
Seagen/Genmab’s confirmatory cervical cancer trial is toplined positive, putting up a fresh roadblock for Iovance’s accelerated filing plans.
More doubts swirl around Lumakras
With sales of the Amgen KRAS inhibitor flatlining an advisory panel is called to discuss its continued US approval.
A short-lived hold for Arcellx & Gilead
Less than two months after a patient death CART-ddBCMA’s pivotal multiple myeloma trial is cleared to restart.
US approval gives Jemperli a treatment niche
However, endometrial cancer remains a small use, and Jemperli has other ways to make a bigger splash.
