"FDA"

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.

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.

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.

Recently, the US FDA has granted orphan drug status to two new therapeutics in a row. One is a small molecule inhibitor, PCLX-001, for the treatment of acute myeloid leukaemia; the other is a T-cell therapy, ET140203, for the treatment of hepatoblastoma. Both therapies are currently in relevant trials.

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 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).