FDA Receives New Drug Application for Ivosidenib in IDH1+ Cholangiocarcinoma

March 01, 2021

A New Drug Application was submitted to the FDA for ivosidenib tablets as a potential treatment option for patients with previously treated IDH1-mutated cholangiocarcinoma. The company is requesting Priority Review be granted to the application.

FDA Issues CRL for Oral Paclitaxel and Encequidar for Metastatic Breast Cancer

March 01, 2021

The FDA has issued a complete response letter to Athenex, Inc, regarding the New Drug Application for oral paclitaxel in combination with encequidar for the treatment of metastatic breast cancer. The FDA stated that the application review process has been completed, but the NDA is not ready for approval due to safety and efficacy concerns.

FDA Approves Melflufen Combination for Triple-Class Refractory Multiple Myeloma

February 27, 2021

The FDA has granted approval to melphalan flufenamide in combination with dexamethasone for the treatment of adult patients with relapsed or refractory multiple myeloma, who have received at least four prior lines of therapy and whose disease is refractory to at least one proteasome inhibitor, one immunomodulatory agent, and one CD38-directed monoclonal antibody.

Cabozantinib Lands Breakthrough Therapy Designation in RAI-Refractory Differentiated Thyroid Cancer

February 26, 2021

The FDA has granted Breakthrough Therapy Designation to cabozantinib for the potential treatment of patients with differentiated thyroid cancer that has progressed following prior therapy and who are radioactive iodine-refractory if eligible for radioactive iodine.