FDA Approvals, News & Updates
On June 10, 2020, the FDA accelerated the approval of a new indication for nivolumab (Opdivo; Bristol Myers Squibb), a PD-1 inhibitor, for the treatment of patients with unresectable advanced, recurrent or metastatic esophageal squamous-cell carcinoma after fluoropyrimidine-based and platinum-based chemotherapy. Nivolumab has been previously approved for many indications, but this is its first indication for esophageal cancer. Read More ›
On May 8, 2020, the FDA accelerated the approval of a new kinase inhibitor, selpercatinib (Retevmo; Loxo Oncology) capsules, for the treatment of 3 types of cancer—metastatic non–small-cell lung cancer (NSCLC), metastatic medullary thyroid cancer, and other types of thyroid cancer—that are associated with RET gene mutations or fusions, as determined by an FDA-approved test. Selpercatinib is the first therapy approved specifically for the treatment of patients with cancer that is linked to RET mutations or fusions. The FDA granted selpercatinib breakthrough therapy and orphan drug designations. Read More ›
On May 6, 2020, the FDA accelerated the approval of oral capmatinib (Tabrecta; Novartis), a kinase inhibitor, for the treatment of adults with metastatic non–small-cell lung cancer (NSCLC). Capmatinib is the first agent approved by the FDA for the treatment of metastatic NSCLC associated with mutations that lead to mesenchymal-epithelial transition (MET) exon 14 skipping, as determined by an FDA-approved test. The FDA granted capmatinib breakthrough therapy and orphan drug designations. Read More ›
On April 17, 2020, the FDA approved pemigatinib (Pemazyre; Incyte), an oral kinase inhibitor, as the first treatment for adults (aged ≥18 years) with previously treated, locally advanced or metastatic cholangiocarcinoma that is associated with a fibroblast growth factor receptor 2 (FGFR2) gene fusion or other rearrangements, as detected by an FDA-approved test. This is the first targeted therapy approved for patients with advanced cholangiocarcinoma. Until now, the standard of therapy for this patient population has been chemotherapy combinations. Read More ›
On May 29, 2020, the FDA approved ramucirumab (Cyramza; Eli Lilly) in combination with erlotinib (Tarceva) for first-line treatment of patients with metastatic non–small-cell lung cancer (NSCLC) and epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) mutations. Ramucirumab was previously approved for several types of cancer, including, in combination with docetaxel, for metastatic NSCLC, after platinum-based chemotherapy. Read More ›
On May 26, 2020, the FDA approved nivolumab (Opdivo; BMS) and ipilimumab (Yervoy; BMS) plus chemotherapy as first-line treatment of recurrent or metastatic squamous or nonsquamous non–small-cell lung cancer (NSCLC), regardless of PD-L1 expression, and with no EGFR or ALK aberrations. On May 15, the FDA approved nivolumab plus ipilimumab as first-line treatment of metastatic NSCLC with PD-L1 ≥1% expression. Read More ›
On May 29, 2020, the FDA approved the immunotherapy atezolizumab (Tecentriq; Genentech), a PD-L1 inhibitor, in combination with bevacizumab (Avastin; Genentech), a vascular endothelial growth factor inhibitor, for the treatment of patients with unresectable or metastatic hepatocellular carcinoma (HCC) who have not received systemic therapy. This is the first immunotherapy regimen approved by the FDA for this type of HCC. Read More ›
On April 15, 2020, the FDA approved the alkylating drug mitomycin gel (Jelmyto; UroGen Pharma) for the treatment of patients with low-grade upper-tract urothelial cancer. Mitomycin is a combination of chemotherapy and a sterile hydrogel that stops the transcription of DNA into RNA and halts the synthesis of protein, thereby blocking the ability of cancer cells to multiply. The FDA granted mitomycin gel priority review, breakthrough therapy, fast track, and orphan drug designations. Read More ›
On April 17, 2020, the FDA approved pemigatinib (Pemazyre; Incyte), an oral kinase inhibitor, as the first treatment for adults (aged ≥18 years) with previously treated, locally advanced or metastatic cholangiocarcinoma that is associated with a fibroblast growth factor receptor 2 (FGFR2) gene fusion or other rearrangements, as detected by an FDA-approved test. This is the first targeted therapy approved for patients with advanced cholangiocarcinoma. Read More ›
On April 17, 2020, the FDA approved tucatinib (Tukysa; Seattle Genetics), an oral kinase inhibitor, in combination with trastuzumab (Herceptin; Genentech) and capecitabine (Xeloda; Genentech) for the treatment of adult patients with advanced unresectable or metastatic HER2-positive breast cancer, including patients with brain metastases, who have received one or more previous anti-HER2–based regimens in the metastatic setting. Read More ›