FDA Approvals - Cancer Currents Blog
- Two-Drug Combination Approved for Lung Cancers with BRAF Mutations
FDA approved the combination of dabrafenib (Tafinlar®) and trametinib (Mekinist®) for the treatment of metastatic non-small cell lung cancer (NSCLC) that has an alteration in the BRAF gene called the V600E mutation.
- New Rituximab Formulation Approved for Some Lymphomas, Leukemia
The FDA has approved a new formulation of rituximab, Rituxan Hycela, that reduces treatment administration time for patients with several types of blood cancer.
- FDA Expands Approval of Ceritinib for ALK-Positive Non-Small Cell Lung Cancer
The FDA has approved the targeted therapy ceritinib as an initial treatment for patients with lung cancer that has a mutation in the ALK gene.
- FDA Approves Pembrolizumab for Tumors with Specific Genetic Features
FDA approved pembrolizumab for patients with solid tumors that have specific genetic features, called mismatch repair deficiency and high microsatellite instability. This is the first approval based on a genetic feature, rather than cancer type.
- FDA Expands Approval of Pembrolizumab for First-Line Treatment of Non-Small Cell Lung Cancer
FDA approved the immune checkpoint inhibitor pembrolizumab to be used with chemotherapy as a first-line treatment for non-small cell lung cancer.
- Midostaurin Approved by FDA for Acute Myeloid Leukemia
The FDA has approved midostaurin for patients with newly diagnosed acute myeloid leukemia (AML) with mutations in the FLT3 gene. The approval also covers several rare conditions.
- FDA Approves Immunotherapy Drugs for Patients with Bladder Cancer
The FDA has approved four immunotherapy drugs—avelumab, atezolizumab, durvalumab, and pembrolizumab—for the treatment of patients with bladder cancer. All four drugs belong to a class of cancer therapies known as checkpoint inhibitors.
- Regorafenib Becomes First FDA-Approved Drug for Liver Cancer in Nearly a Decade
FDA approved the kinase inhibitor regorafenib for some patients with hepatocellular carcinoma, the most common form of liver cancer.
- FDA Grants Brigatinib Accelerated Approval for Metastatic Non-Small Cell Lung Cancer
On April 28, the FDA granted accelerated approval to the targeted therapy brigatinib (Alunbrig™) for patients with metastatic non-small cell lung cancer (NSCLC) and alterations in the ALK gene whose cancer has progressed during their initial therapy.
- FDA Approves Niraparib as Maintenance Therapy for Recurrent Ovarian Cancer
The FDA approved the PARP inhibitor niraparib for use as a maintenance therapy for some women with advanced ovarian cancer.
- FDA Approves Ribociclib, Expands Palbociclib Approval for Metastatic Breast Cancer
The FDA has approved a new targeted therapy, ribociclib, and expanded its earlier approval of another targeted therapy, palbociclib, for some women with metastatic breast cancer.
- Avelumab Becomes First Approved Treatment for Patients with Merkel Cell Carcinoma
The FDA has approved the first drug ever for the rare skin cancer, Merkel cell carcinoma, and updated data show an improved tumor response rate and that patients’ tumors continued to respond for at least a year.
- FDA Approves New Use for Lenalidomide in Multiple Myeloma
The FDA has approved lenalidomide for use as a maintenance therapy in patients with multiple myeloma who have undergone an autologous stem cell transplant, to help keep the cancer from coming back.
- FDA Approves Rucaparib for BRCA-Positive Ovarian Cancer
The FDA has approved rucaparib for women with BRCA-positive advanced ovarian cancer based on findings from two small clinical trials showing that it shrank tumors.
- FDA Approves New Use for Daratumumab in Multiple Myeloma
The FDA has approved daratumumab, in combination with either of two other standard therapies, in patients with multiple myeloma whose disease has progressed after only a single prior treatment course.
- More Immunotherapy Options Approved for Lung Cancer
The FDA has approved atezolizumab and expanded the approval of pembrolizumab for some patients with non-small cell lung cancer.
- Olaratumab Approved to Treat Advanced Soft Tissue Sarcoma
The Food and Drug Administration (FDA) has granted accelerated approval to olaratumab (Lartruvo®) for the treatment of some patients with soft tissue sarcoma.
- FDA Approves Pembrolizumab for Head and Neck Cancer
The approval is for patients with recurrent or metastatic head and neck squamous cell carcinoma that has continued to progress despite standard treatment with chemotherapy.
- Blood Test for Genetic Changes in Tumors Shows Promise as Alternative to Tumor Biopsy
The largest study of its kind to date has shown that a test that assesses DNA mutations and other changes in genetic material shed from tumors into the blood—a liquid biopsy—produced results highly similar to those of traditional tumor biopsies.
- FDA Approves New Immunotherapy Drug for Bladder Cancer
The FDA has approved atezolizumab (Tecentriq®) for the treatment of some patients with urothelial carcinoma, the most common type of bladder cancer.
- Two New Therapies Approved by FDA for Advanced Kidney Cancer
The FDA has approved two drugs, cabozantinib and lenvatinib, for patients whose advanced kidney cancers have progressed after prior treatment with antiangiogenic therapies.
- Venetoclax Approved for Some Patients with Chronic Lymphocytic Leukemia
The FDA has approved venetoclax for patients with chronic lymphocytic leukemia whose tumors have a specific genetic alteration.
- Crizotinib Approval Expanded for Advanced Lung Cancer
The FDA has approved uses of the targeted therapy crizotinib (Xalkori®) for patients with advanced lung cancer whose tumors have alterations in the ROS1 gene.
- FDA Approves Eribulin Mesylate for Advanced Liposarcoma
The FDA has approved eribulin mesylate for patients with liposarcoma whose cancers are advanced or cannot be removed by surgery and are no longer responding to anthracycline-based chemotherapy.
- FDA Approves Alectinib for ALK-Positive Non-Small Cell Lung Cancer
The FDA has approved alectinib to treat patients with metastatic ALK-positive non-small cell lung cancer who have stopped responding to or who are unable to tolerate crizotinib.
- Approval of Osimertinib and Necitumumab Increases Lung Cancer Treatment Options
The FDA has approved two targeted therapies, osimertinib (Tagrisso™) and necitumumab (Portrazza™), for the treatment of some patients with advanced lung cancer.
- FDA Approves Cobimetinib as Part of Drug Combination for Advanced Melanoma
The FDA has approved the targeted drug cobimetinib, in combination with another targeted therapy, to treat patients with advanced melanoma whose tumors have specific genetic mutations.
- FDA Approves Trabectedin to Treat Two Types of Soft Tissue Sarcoma
The FDA has approved trabectedin for patients with advanced liposarcoma and leiomyosarcoma whose cancer has progressed after prior treatment.
- FDA Approves Talimogene Laherparepvec to Treat Metastatic Melanoma
The FDA has approved the first oncolytic virus therapy, talimogene laherparepvec (T-VEC). The drug was approved for the treatment of metastatic melanoma that cannot be removed surgically.
- FDA Approves Irinotecan Liposome to Treat Pancreatic Cancer
Patients with metastatic pancreatic cancer that has progressed after receiving gemcitabine-based chemotherapy now have a new treatment option: irinotecan liposome in combination with fluorouracil and leucovorin.
- FDA Approves Pembrolizumab for Patients with Non-Small Cell Lung Cancer
The FDA has approved the drug pembrolizumab to treat patients with advanced non-small cell lung cancer (NSCLC) whose tumors express a protein called PD-L1.
- FDA Approves Nivolumab for Some Melanomas and Lung Cancers
The FDA has approved nivolumab in combination with ipilimumab for advanced melanoma and nivolumab alone for advanced nonsquamous lung cancer.
- FDA Approves Combination Drug for Patients with Advanced Colorectal Cancer
The FDA has approved a single drug that combines trifluridine and tipiracil to treat patients with metastatic colorectal cancer whose disease progressed after standard treatment.
- FDA Approves Rolapitant to Prevent Nausea and Vomiting from Chemotherapy
The FDA has approved rolapitant to prevent chemotherapy-induced nausea and vomiting.
- FDA Approves Sonidegib for Some Patients with Advanced Basal Cell Carcinoma
The FDA has approved sonidegib for the treatment of patients with locally advanced basal cell carcinoma.
- FDA Approves Expanded Indication for Carfilzomib in Patients with Multiple Myeloma
The FDA has approved carfilzomib in combination with other anticancer drugs to treat patients with relapsed multiple myeloma.
- With FDA Approval, Gefitinib Returns to U.S. Market for Some Patients with Lung Cancer
The FDA last month approved gefitinib (Iressa) for the treatment of some patients with lung cancer, marking the drug’s return to the U.S. market after an earlier withdrawal.
- FDA Approves First Therapy for High-Risk Neuroblastoma
The FDA has approved dinutuximab as part of first-line therapy for children with high-risk neuroblastoma.
- FDA Approves First Immunotherapy Treatment for Lung Cancer
The FDA has approved nivolumab to treat patients with advanced non-small cell lung cancer that has progressed during or after treatment with platinum-based chemotherapy.
- FDA Approves Panobinostat for Some Patients with Multiple Myeloma
The FDA granted accelerated approval of panobinostat for the treatment of multiple myeloma that has progressed after at least two prior standard therapies.
- FDA Approves Lenvatinib for Radioactive Iodine-Refractory Thyroid Cancer
The FDA has approved lenvatinib (Lenvima) to treat some patients with the most common type of thyroid cancer.
- FDA Grants Palbociclib Accelerated Approval for Advanced Breast Cancer
Palbociclib (Ibrance) is approved to be used in combination with letrozole (Femara) to treat postmenopausal women with metastatic breast cancer.
- A Good Year: FDA Approved Nine New Cancer Drugs in 2014
In 2014, the Food and Drug Administration (FDA) approved 41 drugs that had not been approved previously for any indication, the most in nearly 20 years. Of these 41 novel drugs, 9 were approved for the treatment of cancer or cancer-related conditions.