The U.S. Food and Drug Administration approved tisagenlecleucel (Kymriah; Novartis), a CD19-directed genetically modified autologous T-cell immunotherapy, for adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, high grade B-cell lymphoma and DLBCL arising from follicular lymphoma. Read full press release. 

The U.S. Food and Drug Administration approved rucaparib (Rubraca; Clovis Oncology), a poly ADP-ribose polymerase (PARP) inhibitor, for the maintenance treatment of recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy. Read full press release.

The U.S. Food and Drug Administration osimertinib (Tagrisso; AstraZeneca) for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test. Read full press release.

The U.S. Food and Drug Administration granted regular approval to dabrafenib (Tafinlar; Novartis) and trametinib (Mekinist; Novartis) in combination for the adjuvant treatment of patients with melanoma with BRAF 600E or V600K mutations, as detected by an FDA-approved test, and involvement of lymph node(s), following complete resection. Read full press release. 

The U.S. Food and Drug Administration approved nivolumab and ipilimumab (Opdivo and Yervoy; Bristol-Myers Squibb) in combination for the treatment of intermediate or poor risk, previously untreated advanced renal cell carcinoma. Read full press release. 

The U.S. Food and Drug Administration approved everolimus tablets for oral suspension (Afinitor Disperz; Novartis) for the adjunctive treatment of adult and pediatric patients aged 2 years and older with tuberous sclerosis complex (TSC)-associated partial-onset seizures. Everolimus is also approved for two other manifestations of TSC. TSC associated subependymal giant cell astrocytoma (SEGA) and TSC-associated renal angiomyolipoma. Read full press release.

The U.S. Food and Drug Administration approved brentuximab vedotin (Adcentris; Seattle Genomics) to treat adult patients with previously untreated stage III or IV classical Hodgkin lymphoma (cHL) in combination with chemotherapy. Read full press release. 

The U.S. Food and Drug Administrator approved everoliums tablets for oral suspension (Afinitor Disperz; Novartis Pharmaceuticals) for the adjunctive treatment of adult and pediatric patients aged 2 years and older with tuberous sclerosis complex (TSC)-associated partial-onset seizures. Everolimus is also approved for two other manifestations of TSC: TSC-associated subependymal giant cell astrocytoma (SEGA) and TSC-associated renal angiomyolipoma. Read full press release.

The U.S. Food and Drug Administration granted approvals to nivolumab (Opdivo; Bristol-Myers Squibb) and ipilimumab (Yervoy; Bristol-Myers Squibb) in combination for the treatment of intermediate or poor risk, previously untreated advanced renal cell carcinoma. Read full press release. 

The U.S. Food and Drug Administration approved durvalumab (Infinzi; AstraZeneca) for patients with unresectable stage III non-small cell lung cancer (NSCLC) whose disease has not progressed following concurrent platinum-based chemotherapy and radiation therapy. Read full press release.