Jason M. Broderick

A supplemental new drug application has been submitted for ibrutinib (Imbruvica) for use in combination with bendamustine and rituximab to treat patients with relapsed or refractory chronic lymphocytic leukemia.

The use of neoadjuvant chemotherapy in advanced ovarian cancer continues to increase, even though the practice has not been shown to improve survival versus primary cytoreduction.

Optimizing outcomes with novel antibodies in multiple myeloma will involve combination regimens with established agents.

The European Commission has expanded the approval of azacitidine in acute myeloid leukemia to include patients aged ≥65 years who are ineligible for hematopoietic stem cell transplantation and who have >30% myeloblasts.

The FDA expanded the approval of ipilimumab (Yervoy) in melanoma to include adjuvant treatment of patients with stage III melanoma at high risk of recurrence following complete resection.

The FDA has approved talimogene laherparepvec for the treatment of patients with advanced melanoma.

Pembrolizumab (Keytruda) extended overall survival versus docetaxel in the phase II/III KEYNOTE-010 trial.

The FDA has approved trabectedin for the treatment of patients with advanced soft tissue sarcoma, including liposarcoma and leiomyosarcoma subtypes, who have previously received chemotherapy that included an anthracycline.

The FDA issued a complete response letter to Spectrum Pharmaceuticals, informing the company that its new drug application (NDA) for the use of Captisol-enabled melphalan in multiple myeloma will not be approved in its current form.

Acting 3 months ahead of schedule, the FDA approved nivolumab for patients with nonsquamous non–small cell lung cancer previously treated with platinum-based chemotherapy.

The FDA approved pembrolizumab (Keytruda) as a treatment for patients with pretreated advanced non­–small cell lung cancer across all histologies whose tumors express PD-L1.

Nivolumab reduced the risk of death by 27% versus everolimus in patients with advanced renal cell carcinoma, improving overall survival by 5.4 months.

The FDA approved the oral nucleoside TAS-102 (Lonsurf) for the treatment of patients with advanced colorectal cancer, based on results from the phase III RECOURSE trial.

Nivolumab (Opdivo) has received an FDA breakthrough therapy designation for the treatment of patients with advanced renal cell carcinoma.

Alectinib received an FDA priority review designation for patients with ALK-positive, locally advanced or metastatic non–small cell lung cancer (NSCLC) who have progressed or are intolerant to crizotinib (Xalkori).

Adding bevacizumab (Avastin) to a standard chemotherapy doublet reduced the risk of death by 24% and disease progression by 39% in patients with malignant pleural mesothelioma.

Nivolumab (Opdivo) has received an FDA priority review designation for patients with previously treated nonsquamous non–small cell lung cancer.

The FDA has approved rolapitant (Varubi) for use in combination with other antiemetic agents to prevent delayed CINV.

The combination of dabrafenib (Tafinlar) plus trametinib (Mekinist) has been approved in the EU for advanced melanoma.

The FDA has granted elotuzumab (Empliciti) a priority review for use in combination therapy in pretreated patients with multiple myeloma.

The FDA has accepted an application for afatinib (Gilotrif) as a treatment for patients with squamous cell non–small cell lung cancer following progression on chemotherapy.

Patients with follicular lymphoma progressing within 2 years on first-line R-CHOP have a 5-year overall survival rate of only 50%, compared with 90% in longer responders.

Cabozantinib (Cometriq) has received a breakthrough therapy designation from the FDA for the treatment of patients with advanced renal cell carcinoma following one prior therapy.

The European Commission has approved the hedgehog inhibitor sonidegib (Odomzo) for the treatment of patients with locally advanced basal cell carcinoma (laBCC) who are not amenable to curative surgery or radiation therapy.

The FDA has granted a priority review to pembrolizumab (Keytruda) as a frontline treatment for patients with advanced melanoma.

Atezolizumab met the primary endpoint of objective response in PD-L1–positive patients with advanced non–small cell lung cancer in the phase II BIRCH trial.

Achieving true precision medicine with PD-1/PD-L1 agents in NSCLC will only come from biomarker-driven frontline regimens delivered to the right patients.

Corey Langer, MD, discussed the therapeutic potential for anti-HER2 agents in non–small cell lung cancer in a presentation at the 2015 International Lung Cancer Congress.

Paul Bunn, MD, discussed the latest translational advances in NSCLC at the 2015 International Lung Cancer Congress.

Ibrutinib had an overall response rate of 37% in patients with activated B-cell-like diffuse large B-cell lymphoma.