"FDA"

Targeted drug Selpercatinib has received accelerated approval from the FDA. It is cancer-independent and may benefit any solid tumour with a positive RET gene fusion. It is up to 84% effective in selected patients with non-small cell lung cancer!

Elahere, the first antibody-coupled drug (ADC) for refractory ovarian cancer, has received accelerated approval from the FDA, resulting in substantial tumour shrinkage in 31.7% of patients and complete tumour disappearance in 4.8%.

Approval for new FIC depression drug on the horizon!

Was the omission of key data intentional or unintentional?

The US FDA has approved a new leukaemia drug, Olutasidenib, which has been shown to be effective and has a controlled safety profile, resulting in the complete disappearance of cancer cells in 35% of patients enrolled, with efficacy lasting up to 25.9 months.

The US FDA has accelerated the approval of the new drug Pirtobrutinib for the treatment of relapsed or refractory set of cell lymphomas. The drug led to substantial tumour disappearance in 50% of patients, with 13% of them having complete tumour disappearance.

The global ADC drug market will be approximately $5.2 billion by 2021

The US FDA approved a new treatment for non-small cell lung cancer - Tremelimumab + Durvalumab + platinum-based chemotherapy. The triple combination therapy significantly improves efficacy and patient survival and has a good safety profile.

The FDA has recently granted orphan drug designation to Ezurpimtrostat, a PPT-1 inhibitor for the treatment of patients with hepatocellular carcinoma (HCC).

According to an announcement from Caribou Biosciences, the FDA has granted advanced therapy designation in regenerative medicine for the cutting-edge CAR-T therapy CB-010 for the treatment of relapsed or refractory large B-cell lymphoma and fast track designation for the treatment of relapsed or refractory B-cell non-Hodgkin's lymphoma.