To date in 2022, the US FDA has authorised 32 new medication. The final got here on December 12 for Mirati Therapeutics’ (MRTX) Krazati (adagrasib) for non-small cell lung most cancers (NSCLC).
Nevertheless, it appears unlikely that the variety of approvals will exceed that of 2021 when 50 new medication obtained the inexperienced mild from the company. The final time the FDA authorised fewer than 40 new medication was in 2016, when it solely authorised 22.
Nevertheless, with two weeks left in 2022, the FDA nonetheless has a number of PDUFA dates to come back.
The subsequent candidate more likely to be chosen is Coherus BioSciences (CHR) PD-1 inhibitor toripalimab for nasopharyngeal carcinoma. The motion date is December 23.
Toripalimab can be in medical growth for different indications, together with melanoma, esophageal most cancers and NSCLC.
Coherus (CHR) at present markets biosimilars of Neulasta (pegfilgrastim) and Lucentis (ranibizumab).
Gilead Sciences (NASDAQ:BROWN) hopes for approval of lenacapivir, a first-in-class capsid inhibitor for HIV, on December 27. Remedy gained approval within the European Union in August the place it’s marketed as Sunlenca.
Lenacavivir is the one HIV remedy that’s given solely twice a yr. Within the EU it’s indicated for adults with multidrug-resistant HIV an infection.
December 28 could possibly be a giant day for TG Therapeutics (NASDAQ:TGTX) if the corporate receives approval for ublituximab for relapsing a number of sclerosis. The candidate may grow to be TG’s (TGTX) first product marketed since withdrew leukemia remedy Ukoniq (umbralisib) from the market in April.
In search of Alpha contributor Flourishing Capital lately wrote that ublituximab may attain $1 billion in annual gross sales by the top of 2024.
Rock (OTCQX: RHHBY) (OTCQX: RHHBF) may obtain a belated Christmas current if the FDA approves mosunetuzumab for relapsed or refractory follicular lymphoma (“FL”). The organic product obtained ccontinued commercialization in Europe in August as Lunsumio.
If authorised in america, mosunetuzumab would grow to be the primary bispecific antibody authorised for non-Hodgkin’s lymphoma (FL is a sort of this lymphoma). These antibodies are regarded as extra superior than conventional monoclonal antibodies as a result of they assault two illness targets.
Mosunetuzumab is more likely to compete with CAR-T therapies, together with these from Gilead (BROWN) Yescarta (axicabtagene ciloleucel) and Novartis (NVS) Kymriah (tisagenlecleucel). Nevertheless, mosunetuzumab might be extra handy for sufferers as a result of it’s ready-to-use and doesn’t require the manufacturing of the affected person’s personal immune cells.