Go or no go? Mirati heads to the FDA

With the end of 2022 in sight, several important FDA approval decisions are still on the cards, including an accelerated verdict on Mirati’s adagrasib. A green light would set the Kras inhibitor up for a battle against Amgen’s rival drug Lumakras, so any differences in labels will be key.

Elsewhere, TG Therapeutics will be hoping to forget its troubled oncology past with an approval for ublituximab in multiple sclerosis, but a crowded market awaits. Also, while Gilead’s long-acting lenacapavir looks set for a thumbs-up in heavily pretreated HIV patients, a bigger commercial opportunity lies in earlier lines of therapy.