Diana Ernst, RPh

The kinase inhibitor was previously approved for this indication under the FDA’s accelerated pathway based on overall response rate and duration of response.

Obe-cel is an investigational autologous CAR T-cell therapy designed with a fast off-rate CD19 binder to reduce toxicity and increase long-term persistence.

The updates were prompted by findings from an investigation of reports describing mature T-cell malignancies among patients treated with these therapies.

Jylamvo contains 2mg of methotrexate per mL and is packaged in bottles containing 60mL of oral solution.

The FDA has approved Avzivi (bevacizumab-tnjn), a biosimilar to Avastin (bevacizumab).

The FDA has approved Akeega (niraparib and abiraterone acetate) to treat BRCA-mutated metastatic castration-resistant prostate cancer.

Elrexfio is expected to be available in the coming weeks.

The FDA has granted full approval to Gavreto (pralsetinib) for the treatment of adults with metastatic RET fusion-positive NSCLC.

The FDA has granted accelerated approval to Talvey (talquetamab) for the treatment of adults with relapsed/refractory multiple myeloma who have received at least 4 prior lines of therapy.

Keytruda is a programmed death receptor-1 (PD-1)-blocking antibody.