"FDA"

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.

Approval for new FIC depression drug on the horizon!

Was the omission of key data intentional or unintentional?

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

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%.

The FDA has granted accelerated approval to Adagrasib for the treatment of patients with KRAS G12C mutations in non-small cell lung cancer. In the trial, the drug resulted in disease control in 80% of patients, of which, 43% had substantial tumour shrinkage.

Pfizer's new treatment, Elranatamab, has received Breakthrough Therapy designation from the FDA for the treatment of patients with relapsed or refractory multiple myeloma. Data from the trial showed a patient efficacy rate of 61.0% and that once the therapy is effective, efficacy is maintained for more than six months in over 90% of patients!

Data from a study recently published by the Royal Marsden Cancer Centre showed promising data for the combination of Avutometinib + Defactinib in the treatment of ovarian cancer, resulting in significant tumour shrinkage in 28% of patients and disease control in 93% of patients.

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

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.