Articles related to DEVICE/DRUG APPROVALS

This new indication marks the second FDA approval for sacituzumab govitecan (Trodelvy, Immunomedics) and was based on the phase 2, single-arm TROPHY-U-01 main efficacy endpoints in objective response rate (ORR) and duration of response (DOR). With a relative 5-year survival rate of 5.5%, this is a significant advancement for patients with metastatic urothelial cancer (mUC), the most common type of bladder cancer.

The approval of the new cetuximab (Erbitux) dosage – 500 mg/m2 as a two-hour IV infusion every two weeks – was based on population pharmacokinetic (PK) modeling analyses and provides an alternative option to the previously approved weekly dose. Cetuximab can be dosed alone or in combination with chemotherapy.

From the pages of Oncology Times comes the latest approvals, designations, and new indications from the U.S. Food and Drug Administration (FDA) for oncology drugs. Stories include new approvals in multiple myeloma, esophageal or gastroesophageal junction (GEJ) carcinoma, non-small cell lung cancer (NSCLC), anaplastic lymphoma, and more.

The approval of the drug (Fotivda, Aveo Pharmaceuticals) was based on the results of the open-label, multi-center TIVO-3 trial, which looked at progression-free survival (PFS) as the main efficacy endpoint, assessed by a blinded independent radiology review committee. Secondary end points included overall survival (OS) and objective response rate (ORR).

More good news for zanubrutinib, which received accelerated approval in November 2019 in the US for the treatment of mantle cell lymphoma (MCL) in adult patients who have undergone at least one prior therapy. The supplemental new drug application (sNDA) was submitted by the drug’s manufacturer, BeiGene, based on data from the global phase III ASPEN trial.

This “Clinical Trials & Observations” report from Blood Advances (ASH)  explores the implications of the recently approved anemia treatment luspatercept, which can now be prescribed in the second-line setting after erythropoiesis-stimulating agents (ESAs) have failed or for patients who are not eligible because of high serum erythropoietin (sEPO) levels. A downloadable visual abstract helps paint the picture as well.