"FDA"

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 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.

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.

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.

Approval for new FIC depression drug on the horizon!

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 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.

Was the omission of key data intentional or unintentional?

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.