Jason M. Broderick

The FDA has accepted new drug applications supporting use of the combination of the BRAF inhibitor encorafenib and the MEK inhibitor binimetinib for BRAF-mutant advanced, unresectable or metastatic melanoma.

Adding the IDO inhibitor indoximod to pembrolizumab (Keytruda) led to an overall response rate of 61% in patients with advanced melanoma.

Duvelisib reduced the risk of disease progression or death by 48% versus ofatumumab (Arzerra) in patients with relapsed/refractory chronic lymphocytic leukemia or small lymphocytic lymphoma.

The FDA released a statement today providing specific data from 2 phase III trials of pembrolizumab in multiple myeloma that the agency placed clinical holds on in July.

The FDA has accepted a supplemental new drug application seeking to add overall survival data from the phase III ENDEAVOR trial to the label for carfilzomib for use in patients with relapsed or refractory multiple myeloma.

The FDA has extended its decision deadline by 3 months on a biologics license application for MYL-1401O, a trastuzumab biosimilar co-developed by Mylan and Biocon. A final decision is expected on or before December 3, 2017.

The FDA issued a historic approval of the first chimeric antigen receptor (CAR) T-cell therapy, authorizing the use of tisagenlecleucel (Kymriah) for the treatment of patients up to 25 years of age with B-cell precursor acute lymphoblastic leukemia that is refractory or in second or later relapse.

The FDA has accepted a resubmitted new drug application for Lutathera (lutetium [177Lu] oxodotreotide) for the treatment of patients with gastroenteropancreatic neuroendocrine tumors.

The FDA has approved fulvestrant for use in hormone receptor-positive, HER2-negative locally-advanced or metastatic breast cancer in postmenopausal women not previously treated with endocrine therapy.

The European Commission has approved the CDK 4/6 inhibitor ribociclib for use in combination with an aromatase inhibitor for the frontline treatment of postmenopausal women with hormone-receptor (HR)–positive, HER2-negative locally advanced or metastatic breast cancer.

The FDA has approved ibrutinib for the treatment of adult patients with chronic graft versus host disease following the failure of 1 or more lines of systemic therapy. The BTK inhibitor is now the first FDA-approved therapy for the treatment of cGVHD.

The FDA has granted an accelerated approval to nivolumab for the treatment of adult and pediatric patients with microsatellite instability-high or mismatch repair deficient metastatic colorectal cancer that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan.

Venetoclax has received an FDA breakthrough therapy designation for use in combination with low dose cytarabine in treatment-naïve elderly patients with acute myeloid leukemia who are ineligible for intensive chemotherapy.

The FDA has approved ipilimumab for the treatment of patients aged ≥12 years with unresectable or metastatic melanoma.

The European Medicines Agency's Committee for Medicinal Products for Human Use has recommended approval of obinutuzumab in the frontline setting for the treatment of patients with follicular lymphoma.

The European Medicines Agency's Committee for Medicinal Products for Human Use has recommended approval of Lutathera for the treatment of patients with unresectable or metastatic, progressive, well-differentiated, somatostatin receptor positive gastroenteropancreatic neuroendocrine tumors.

The FDA has approved neratinib (Nerlynx) for the extended adjuvant treatment of patients with early stage, HER2-positive breast cancer following postoperative trastuzumab.

The FDA has granted a priority review to a new drug application for the CDK4/6 inhibitor abemaciclib as a treatment for patients with advanced hormone receptor–positive, HER2-negative breast cancer.

The FDA has approved subcutaneous rituximab (Rituxan Hycela) for the treatment of adults with previously untreated and relapsed or refractory follicular lymphoma, previously untreated diffuse large B-cell lymphoma, and previously untreated and previously treated chronic lymphocytic leukemia.

A supplemental Biologics License Application has been submitted to the FDA for brentuximab vedotin (Adcetris) as a treatment for patients with cutaneous T-cell lymphoma (CTCL), according to Seattle Genetics, which codevelops the antibody-drug conjugate with Takeda.

The FDA has accepted a supplemental biologics license application for the use of denosumab (Xgeva) for the prevention of skeletal-related events in patients with multiple myeloma.

The FDA has approved daratumumab for use in combination with pomalidomide and dexamethasone for patients with multiple myeloma who have received at least 2 prior therapies, including a proteasome inhibitor and lenalidomide.

Although FLT3 mutations are well established as a prognostic marker in patients with AML, efforts to target the aberration therapeutically were underway for more than 15 years before yielding success.

Combining the PD-L1 inhibitor avelumab (Bavencio) with the VEGF inhibitor axitinib (Inlyta) as a frontline regimen induced a response rate of 58.2% in patients with advanced renal cell carcinoma, according to findings from the phase Ib JAVELIN Renal 100 trial presented at the 2017 ASCO Annual Meeting.

Combining the PD-1­ inhibitor pembrolizumab with the IDO1 inhibitor epacadostat led to an overall response rate of 35% in patients with advanced urothelial carcinoma.

Pembrolizumab (Keytruda) showed durable antitumor activity in patients with heavily pretreated metastatic triple-negative breast cancer (TNBC), according to findings from cohort A of the phase II KEYNOTE-086 trial presented at the 2017 ASCO Annual Meeting.

Nivolumab plus ipilimumab demonstrated an intracranial response rate of 42% in asymptomatic patients with melanoma brain metastases who had not received prior local therapy to the brain.

The PARP inhibitor olaparib (Lynparza) reduce the risk of disease progression by 42% versus standard chemotherapy in patients with BRCA-positive, HER2-negative breast cancer, according to findings from the phase III OLYMPIAD trial.

Combining the PD-1 inhibitor pembrolizumab (Keytruda) with the HDAC inhibitor entinostat demonstrated promising clinical activity and acceptable safety in patients with melanoma who were refractory to immune checkpoint inhibitors.

Adding the CDK4/6 inhibitor abemaciclib to fulvestrant reduced the risk of disease progression or death by 45% versus fulvestrant alone in pretreated patients with HR+/HER2-negative breast cancer, according to findings presented at the 2017 ASCO Annual Meeting.