2019 has seen some exciting innovations in the Oncology and Hematology pipeline. Below are a few of the many newly approved products as featured on DocWire News.
1: FDA Expands Use of Breast Cancer Drug to Include Men
The U.S. Food and Drug Administration (FDA) expanded the approval of palbociclib (IBRANCE) in combination with endocrine therapy for hormone receptor (HR)-positive, human epidermal growth factor receptor 2-negative advanced or metastatic breast cancer in male patients.
2: FDA Approves Firstline Lung Cancer Combination
The U.S. Food and Drug Administration (FDA) approved atezolizumab (TECENTRIQ®) in combination with carboplatin and etoposide for firstline treatment of adults with extensive-stage small cell lung cancer.
The decision was based on results from the multicenter, double-blinded, randomized, placebo-controlled, phase III IMpower133 study, which enrolled 403 patients who were randomized 1:1 to receive atezolizumab in combination with carboplatin and etoposide (n=201) or placebo in combination with carboplatin and etoposide (control arm; n=202).
3: FDA Approves LONSURF for Gastric Cancers
The U.S. Food and Drug Administration approved the oral agent trifluridine/tipiracil (LONSURF) to treat adult patients with metastatic gastric or gastroesophageal junction adenocarcinoma who previously received at least two prior lines of chemotherapy that included a fluoropyrimidine, a platinum, either a taxane or irinotecan, and if appropriate, human epidermal growth factor receptor 2/neu-targeted therapy.
4: FDA Approves First Treatment CABLIVI for Rare Blood Disease
The U.S. Food and Drug Administration approved caplacizumab-yhdp (CABLIVI) injection as the first treatment specifically indicated for the treatment of adults with acquired thrombotic thrombocytopenic purpura (aTTP) in combination with plasma exchange and immunosuppressive therapy.
5: FDA Approves Non-Chemotherapy Combination for CLL and SLL
The U.S. Food and Drug Administration approved ibrutinib (IMBRUVICA) in combination with obinutuzumab (GAZYVA) for treatment-naïve patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma. This is the first non-chemotherapy regimen indicated for this patient population.
6: FDA Approves Second-Line Liver Cancer Therapy
The U.S. Food and Drug Administration approved cabozantinib for patients with hepatocellular carcinoma (HCC) who have previously received sorafenib.
The decision was based on results from the randomized, double-blind, placebo-controlled, phase III, pivotal CELESTIAL trial that was designed to enroll 760 patients with advanced HCC who received prior sorafenib and may have received up to two prior systemic therapies for HCC and had adequate liver function. Patients were enrolled from more than 100 sites in 19 countries and were randomized 2:1 to receive cabozantinib 60 mg once daily or placebo