The additional approval expands immunization coverage to the most at-risk group for acquiring shingles – the immunocompromised. It also shortens the time to the second dose in the 2-dose Shingrix schedule. Decision support based on the Zoster Efficacy Study in Patients Undergoing HSCT (ZOE-HSCT) phase III trial (JAMA).
Despite the pandemic interrupting trials and drug development in 2020, the US Food and Drug Administration (FDA) claims it is “full speed ahead” on the approval of novel cancer drug therapies. The authors of this Journal of the American Medical Association (JAMA) study wanted to verify these remarks, reviewing the FDA Hematology/Oncology Approvals website to […]
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 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 […]
Despite the COVID-19 pandemic seemingly putting a hold on everything, approvals of new drugs have not waned. In fact, despite their high price tags – median prices ranged from $766 million to $2.8 billion – new drugs continue to roll out in 2021. Here are five new drugs approved this year that you may find […]
Another win for Merck and Keytruda, as the FDA granted accelerated approval to pembrolizumab in combination with chemotherapy for the treatment of patients with locally recurrent unresectable or metastatic triple-negative breast cancer (TNBC) whose tumors express PD-L1 based on PFS. The FDA also approved a companion diagnostic, PD-L1 IHC 22C3 pharmDx.
The US Food and Drug Administration (FDA) approval – the first for mesothelioma in 16 years and the second FDA-approved systemic therapy for mesothelioma – was based on a randomized, open-label trial, of 605 patients. The endpoint was to determine if the nivolumab-ipilimumab combo improved overall survival compared to chemotherapy.