FDA Approvals, News & Updates
- Introduction
- Oncology Overview
- Breast Cancer New Indications
- Genitourinary Cancers New Indications
- Gynecologic Cancers New Indications
- Hematologic Malignancies New Indications
- Lung Cancer New Indications
- Other Tumor Types New Indications
On June 10, 2019, the US Food and Drug Administration (FDA) granted accelerated approval to the novel antibody-drug conjugate polatuzumab vedotin-piiq (Polivy; Genentech) in combination with bendamustine plus rituximab for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) that has progressed or returned after at least 2 previous therapies. This is the first chemoimmunotherapy regimen approved for use in patients with DLBCL who are ineligible for hematopoietic stem-cell transplantation. Read More ›
On May 2, 2019, the FDA expanded the indication for ivosidenib (Tibsovo; Agios Pharmaceuticals), an oral isocitrate dehydrogenase-1 (IDH1) inhibitor, to include the treatment of patients with newly diagnosed acute myeloid leukemia (AML) and a susceptible IDH1 mutation, as detected by an FDA-approved companion diagnostic test, who are aged ≥75 years or who have comorbidities that preclude the use of intensive induction chemotherapy. Tibsovo was previously approved for the treatment of patients with relapsed or refractory AML with a susceptible IDH1 mutation. Read More ›
On April 12, 2019, the FDA accelerated the approval of erdafitinib (Balversa; Janssen), a fibroblast growth factor receptor (FGFR) kinase inhibitor, for the treatment of adults with locally advanced or metastatic urothelial carcinoma and FGFR3 or FGFR2 genetic alterations, as detected by an FDA-approved test, whose disease progressed during or after ≥1 lines of platinum-containing chemotherapy, making it the first targeted drug to receive approval for this patient population. Read More ›
On April 19, 2019, the FDA accelerated the approval of pembrolizumab (Keytruda; Merck) plus axitinib (Inlyta; Pfizer) for the first-line treatment of patients with advanced renal-cell carcinoma (RCC). Keytruda has received previous FDA approval as a single agent or in combination with other agents for the treatment of many types of cancers. Read More ›
On April 19, 2019, the US Food and Drug Administration (FDA) approved a combination of pembrolizumab (Keytruda; Merck) plus axitinib (Inlyta; Pfizer) for the first-line treatment of patients with advanced renal-cell carcinoma (RCC), making it the first immunotherapy combination regimen approved for patients with this disease. Read More ›
In This Article:
- Another Approval for Keytruda and An Easing of Pregnancy Restrictions for Women Taking Soltamox
- FDA Advises Women to Avoid Pregnancy for Only 2 Months After Final Dose of Soltamox
On February 22, 2019, the FDA approved a new indication for trifluridine plus tipiracil (Lonsurf; Taiho Pharmaceuticals), an oral combination of a nucleoside metabolic inhibitor and a thymidine phosphorylase inhibitor for the treatment of patients with metastatic gastric or gastroesophageal junction adenocarcinoma who received ≥2 lines of chemotherapy regimens with a fluoropyrimidine, a platinum, a taxane or irinotecan, and, if appropriate, HER2/neu-targeted therapy. Read More ›
On February 28, 2019, the FDA approved a combination of the HER2/neu receptor agonist trastuzumab plus the endoglycosidase hyaluronidase-oysk (Herceptin Hylecta; Genentech) subcutaneous (SC) injection for adults with HER2-overexpressing breast cancer in the adjuvant setting, as part of a regimen with chemotherapy or as monotherapy after multimodality anthracycline-based therapy; and as first-line treatment for metastatic disease, in combination with paclitaxel, or as monotherapy after ≥1 chemotherapies in the metastatic setting. Read More ›
On March 1, 2019, the FDA accelerated the approval of atezolizumab (Tecentriq; Genentech) plus nab-paclitaxel (Abraxane; Celgene) for the treatment of patients with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) and PD-L1 expression, as identified by an FDA-approved test. Tecentriq was previously approved for bladder cancer and for non–small-cell lung cancer. This is the first FDA approval of an immunotherapy for patients with metastatic TNBC. Read More ›