"FDA"

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!

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.

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.

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.

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 FDA granted Fast Track designation to a new drug, IK-175, in combination with nabumab for the treatment of advanced uroepithelial carcinoma, after preliminary trial data showed encouraging and durable anti-tumor activity with a favorable safety profile.

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.

The US FDA has approved pemigatinib, the first targeted drug to date for patients with specific mutated blood tumours, and the results of the study show that the drug made tumours disappear completely in 79% of patients!

The FDA granted priority review status to Enhertu (DS-8201) for the treatment of patients with HR-positive, low HER2-expressing breast cancer, and Enhertu has enabled these patients to remain disease-free for an average of 10.1 months, with an average overall survival time of nearly two years. A decision on approval is expected to be made in the fourth quarter of this year.

The US Food and Drug Administration has approved Vabysmo (faricimab-svoa), for the treatment of wet age-related macular degeneration (AMD) and diabetic macular oedema (DME).