I was reading the 2022 FDA approval list to get a better sense of what's getting over the finish line (Endpoints article here). Some interesting things:

 

• The first TCR therapy approval (Kimmtrak from Immunocore) happened this year. This serves as alternative type of T cell engager that uses neoantigen pMHC on a tumor cell as the target for the engager (in this case, gp100) instead of a cell surface receptor (like CD19 or CD20).
   

• Seems BCMA (B cell maturation antigen) might be the next CD19 or CD20 in terms of being the low hanging fruit/proving ground. JnJ scored on two fronts -- Carvykti (CAR-T) and Tecvayli (CD3xBCMA bispecific)
   

• Lunsumio from Genentech is a CD3xCD20 bispecific and I believe the first CD20 bispec approved.
   

• Clearly, T cell engagers (even if less efficacious than CAR-T) will continue to grow. Interesting to note how much of the development so far has been focused on the tumor-targeting side. Not much has happened on the T cell recruiting side (always aCD3). This is most likely because you need CD3 cross linking to activate bystander T cells, but we may see an increase in the future on engaging more specific populations.
   

• Mounjaro (Tirzepatide) is Eli Lilly's GLP1R/GIP agonist
   

• Hemgenix is an in vivo AAV gene therapy for Hem B F9 replacement. Important to contextualize just how hard in vivo viral gene therapy is -- this is only the 3rd FDA approval after Luxturna/Zolgensma.
   

• There was another in vivo AAV GTx approved at the end of December, Adstiladrin. This didn't pick up a lot of traction (probably because niche indication) but is actually really remarkable as it's a locally delivered AAV encoding for IFNa.
   

• First microbiome approval. I think it's just FMT, but important regulatory step in the right direction
   

• Amvuttra from Alnylam is a next-gen of Onpattro that can be given subcutaneous every 3 months instead of IV every 3 weeks as Onpattro. Pretty incredible that just 5 years after first-in-class RNAi approval of Onpattro, we already have a better version that seems miles better from a patient administration perspective
   

• Sunlencia from Gilead is an HIV antiviral that finally got approved after initial rejection earlier in the year because of... the glass vials. Just insane stuff that you can have an effective therapy but quality of glass vials can derail your FDA approval