"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 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.

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!

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

The US FDA has approved pablizumab (Keytruda) as an adjuvant treatment for early-stage non-small cell lung cancer. In the trial, pablizumab (Keytruda) significantly prolonged cancer-free survival in patients compared to placebo.

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 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).