Jason M. Broderick

Nivolumab (Opdivo) has been granted an accelerated approval by the FDA 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.

The FDA has granted breakthrough therapy designation to venetoclax (Venclexta) for use in combination with low dose cytarabine (LDAC) in treatment-naïve elderly patients with acute myeloid leukemia (AML) who are ineligible for intensive chemotherapy, according to Roche, which is codeveloping the BCL-2 inhibitor with AbbVie.

Lutathera (lutetium [¹⁷⁷Lu] oxodotreotide) has been recommended for approval by the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) for the treatment of patients with unresectable or metastatic, progressive, well-differentiated (grade 1 and grade 2), somatostatin receptor positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs).

Obinutuzumab (Gazyvaro, EU; Gazyva, US) has been recommended for approval by the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) in the frontline setting for the treatment of patients with follicular lymphoma.

Ipilimumab (Yervoy) has been approved by the FDA for the treatment of patients aged ≥12 years with unresectable or metastatic melanoma, according to Bristol-Myers Squibb (BMS), the manufacturer of the CTLA-4 inhibitor.

Neratinib (Nerlynx) has been approved by the FDA for the extended adjuvant treatment of patients with early stage HER2-positive breast cancer following postoperative treatment with trastuzumab (Herceptin). 

A new drug application (NDA) for abemaciclib has been granted a priority review by the FDA as a treatment for patients with advanced hormone receptor (HR)­­–positive, HER2-negative breast cancer.

In patients with heavily pretreated metastatic triple-negative breast cancer, pembrolizumab showed durable antitumor activity, according to findings from cohort A of the phase II KEYNOTE-086 trial.

Subcutaneous rituximab has been approved by the FDA 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 CLL.

A supplemental biologics license application for the use of denosumab for the prevention of skeletal-related events in patients with multiple myeloma has been accepted by the FDA.

Daratumumab has been approved by the FDA 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.

The combination of the PD-L1 inhibitor avelumab with the VEGF inhibitor axitinib as a frontline regimen for advanced renal cell carcinoma induced a response rate of 58.2% in patients with advanced renal cell carcinoma.

When epacadostat, an IDO1 inhibitor, was combined with pembrolizumab (Keytruda), a PD-1 inhibitor, responses were seen in 35% of patients with advanced urothelial carcinoma, according to findings presented during the 2017 ASCO Annual Meeting.  

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. 

The risk of disease progression or death was reduced by 45% with the addition of abemaciclib to fulvestrant compared with that of fulvestrant alone in patients with previously treated HR-positive/HER2-negative breast cancer, according to findings presented during the 2017 ASCO Annual Meeting.

Sunitinib (Sutent) has been granted a priority review designation by the FDA for use as an adjuvant therapy in patients with renal cell carcinoma who have received nephrectomy and are high risk for recurrence.

Ceritinib (Zykadia) has been approved by the FDA for the treatment of patients with <em>ALK</em>-positive, metastatic non&ndash;small cell lung cancer.

Nivolumab (Opdivo) has been granted a priority review designation by the FDA for use as a treatment for patients with hepatocellular carcinoma following prior sorafenib (Nexavar).

Neratinib has been recommended for approval by the FDA&rsquo;s Oncologic Drugs Advisory Committee in a 12-4 vote&nbsp;for the extended adjuvant treatment of patients with early stage, HER2-positive breast cancer following postoperative trastuzumab.

Pembrolizumab (Keytruda) has been granted an accelerated approval by the FDA&nbsp;for the treatment of adult and pediatric patients with unresectable or metastatic, microsatellite instability-high or mismatch repair deficient solid tumors.

Ceritinib (Zykadia) has been recommended for approval by the EMA&rsquo;s Committee for Medicinal Products for Human Use for the treatment of patients with ALK-positive, metastatic non&ndash;small cell lung cancer.

Pembrolizumab (Keytruda) has been approved by the FDA for the treatment of patients with locally advanced or metastatic urothelial carcinoma.

Copanlisib has been granted a priority review designation by the FDA as a treatment for patients with relapsed/refractory follicular lymphoma who have received at 2 least prior therapies.

Entrectinib has been granted breakthrough therapy designation by the FDA&nbsp;for use as a treatment for adult and pediatric patients with <em>NTRK</em>-positive, locally advanced or metastatic solid tumors.

The BRAF inhibitor encorafenib combined with the MEK inhibitor binimetinib reduced the risk of disease progression or death by 23% compared with single-agent encorafenib for patients with&nbsp;<em>BRAF</em>-mutant melanoma.

Pembrolizumab (Keytruda) has been granted an accelerated approval&nbsp;by the FDA for use in combination with pemetrexed plus carboplatin as a frontline treatment for patients with metastatic or advanced nonsquamous non&ndash;small cell lung cancer, regardless of PD-L1 expression.

Atezolizumab failed to meet the primary endpoint of improving overall survival in the second-line setting for patients with locally advanced or metastatic urothelial carcinoma.

An accelerated approval for the PD-L1 inhibitor avelumab (Bavencio) has been granted by the FDA for the treatment of patients with locally advanced or metastatic urothelial carcinoma.

Pembrolizumab has been approved by the European Commission for the treatment of adult patients with relapsed or refractory classical Hodgkin lymphoma.

The PD-L1 inhibitor durvalumab has been granted an accelerated approval by the FDA for the treatment of patients with locally advanced or metastatic urothelial carcinoma.