"FDA"

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 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 US FDA has approved Elacestrant, the first oral selective estrogen receptor degrader (SERD), for the treatment of patients with advanced or metastatic breast cancer who are estrogen receptor positive, HER2 negative and have an ESR1 mutation. Results of the trial showed that patients treated with Elacestrant had a 45% reduction in the risk of disease progression or death.

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 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.

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 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).