Bet_Noire
So far in 2022, the US FDA has approved 32 novel drugs. The last came on Dec. 12 for Mirati Therapeutics’ (MRTX) Krazati (adagrasib) for non-small cell lung cancer (NSCLC).
However, it appears unlikely that the number of approvals will not surpass that of 2021’s total when 50 new drugs were given the green light from the agency. The last time the FDA approved fewer than 40 new medicines was 2016 when it approved just 22.
However, given there are two weeks left in 2022, the FDA still has several PDUFA dates forthcoming.
The next candidate that could win approval is Coherus BioSciences’ (CHRS) PD-1 inhibitor toripalimab for nasopharyngeal carcinoma. The action date is Dec. 23.
Toripalimab is also in clinical development for other indications, including melanoma, esophageal cancer, and NSCLC.
Coherus (CHRS) currently markets biosimilars of Neulasta (pegfilgrastim) and Lucentis (ranibizumab).
Gilead Sciences (NASDAQ:GILD) is hoping for approval of lenacapivir, a first-in-class capsid inhibitor for HIV, on Dec. 27. The drug won approval in the European Union in August where it is marketed under the name Sunlenca.
Lenacapivir is the only HIV treatment that is given only twice a year. In the EU, it is indicated for adults with multi-drug resistant HIV infection.
Dec. 28 could be a big day for TG Therapeutics (NASDAQ:TGTX) if the company receives approval of ublituximab for relapsing multiple sclerosis. The candidate could become TG’s (TGTX) first marketed product since it withdrew the leukemia treatment Ukoniq (umbralisib) from the market in April.
Seeking Alpha contributor Flourishing Capital recently wrote that ublituximab could hit $1B in annual sales by the end of 2024.
Roche (OTCQX:RHHBY) (OTCQX:RHHBF) could receive a late Christmas gift if the FDA approves mosunetuzumab for relapsed or refractory follicular lymphoma (“FL”). The biologic received conditional marketing in Europe in August under the name Lunsumio.
If approved in the US, mosunetuzumab would become the first bispecific antibody approved for non-Hodgkin’s lymphoma (FL is a type of this lymphoma). These antibodies are thought to be more advanced than traditional monoclonal antibodies as they engage two disease targets.
Mosunetuzumab is likely to compete against CAR-T therapies, including Gilead’s (GILD) Yescarta (axicabtagene ciloleucel) and Novartis’ (NVS) Kymriah (tisagenlecleucel). However, mosunetuzumab is likely more convenient for patients as it is off the shelf and doesn’t require a patient’s own immune cells to produce.
