Jason M. Broderick

Over one-fourth of patients with metastatic melanoma in Europe do not have access to groundbreaking therapies that could extend their lives.

As the FDA considers a supplemental biologics license application for 2 daratumumab-based triplet regimens in multiple myeloma, the results for 1 of the pivotal phase III studies supporting the sBLA have been published in The New England Journal of Medicine.

The FDA has granted a breakthrough therapy designation to alectinib (Alecensa) as a frontline treatment for patients with ALK-positive non–small cell lung cancer.

There have been 10 agents approved over the last 12 years for the treatment of patients with multiple myeloma, and pivotal data for each agent has supported rapid inclusion into the NCCN treatment algorithms.

Ruben Mesa, MD, discussed the latest NCCN treatment guidelines for myelofibrosis and emerging treatments in the field.

Stephen K. Chia, MD, highlights the key findings from the KRISTINE and NSABP B-41 trials and their implications for the treatment of HER2-positive breast cancer.

A supplemental new drug application has been submitted to the FDA for the use of ibrutinib as a treatment for patients with marginal zone lymphoma.

Ceritinib improved progression-free survival compared with standard chemotherapy as a first-line treatment for patients with ALK-positive non–small cell lung cancer.

Combining the diabetes drug metformin with everolimus and letrozole resulted in a clinical benefit rate of 60% in women with advanced or recurrent endometrioid endometrial cancer.

The European Medicines Agency has validated a type II variation application for use of nivolumab (Opdivo) as a treatment for patients with locally advanced unresectable or metastatic urothelial carcinoma who have progressed following platinum-based chemotherapy.

The Committee for Medicinal Products for Human Use has recommended approval of palbociclib for patients with HR-positive, HER2-negative metastatic breast cancer, either in combination with an aromatase inhibitor in the frontline setting, or combined with fulvestrant after progression on endocrine therapy.

The Committee for Medicinal Products for Human Use has recommended approval of the PDGFRα antagonist olaratumab for use in combination with doxorubicin for patients with advanced soft tissue. sarcoma who are not good candidates for radiotherapy or surgery.

The European Commission has approved lenvatinib (Kisplyx) in combination with everolimus for patients with advanced renal cell carcinoma following 1 prior VEGF-targeted therapy.

The European Commission has approved cabozantinib for the treatment of patients with advanced renal cell carcinoma after the failure of VEGF-targeted therapy, according to Exelixis and Ipsen, the manufacturers of the multikinase inhibitor.

The FDA’s Oncologic Drugs Advisory Committee voted 14-0 against approving apaziquone (EOquin; Qapzola) for intravesical instillation immediately following transurethral resection in patients with non-muscle invasive bladder cancer.

The future of imetelstat as a treatment for patients with myelodysplastic syndromes is uncertain following an update on 2 clinical trials.

The FDA has granted a priority review to a supplemental biologics license application for pembrolizumab (Keytruda) as a first-line treatment for patients with PD-L1–positive non–small cell lung cancer.

Selinexor (KPT-330) demonstrated promising clinical activity in patients with heavily pretreated multiple myeloma.

The FDA has granted an accelerated approval to blinatumomab (Blincyto) for the treatment of pediatric and adolescent patients with Philadelphia chromosome-negative relapsed or refractory B-cell precursor acute lymphoblastic leukemia.

Atezolizumab (Tecentriq) improved survival compared with docetaxel in patients with advanced non–small cell lung cancer following the failure of platinum-based chemotherapy.

Bruce Cheson, MD, discusses how frontline treatment for chronic lymphocytic leukemia has evolved well beyond a "one-size-fits-all" approach, with patient and disease characteristics and physician/patient discussions determining the optimal therapeutic approach.

Jennifer Woyach, MD, discussed using the FDA-approved agents ibrutinib (Imbruvica), idelalisib (Zydelig), and venetoclax (Venclexta) in a hypothetical patient scenario, and highlighted emerging targets and treatments in relapsed/refractory chronic lymphocytic leukemia.

The FDA has granted a priority review to a new drug application for rucaparib as a treatment for patients with BRCA-positive advanced ovarian cancer who have received at least 2 prior lines of chemotherapy.

The European Medicines Agency has validated the marketing authorization application for neratinib as a potential extended adjuvant therapy for patients with HER2-positive early stage breast cancer following 12 months of trastuzumab.

A supplemental biologics license application has been submitted to the FDA for the use of daratumumab (Darzalex) in combination with lenalidomide and dexamethasone or bortezomib and dexamethasone as a treatment for patients with multiple myeloma following at least 1 prior therapy.

Adding custirsen to cabazitaxel (Jevtana) and prednisone in the second-line setting failed to improve overall survival in men with metastatic castration-resistant prostate cancer in the phase III AFFINITY trial.

The phase III MONARCH 2 study assessing abemaciclib in HR-positive, HER2-negative advanced breast cancer will continue after the CDK4/6 inhibitor did not meet the efficacy criteria at an interim analysis required to stop the trial early.

The FDA has approved an extended release injection formulation of granisetron (Sustol) for use in combination with other antiemetic therapies for the prevention of chemotherapy-induced nausea and vomiting.

Combination therapy with cobimetinib (Cotellic) and vemurafenib (Zelboraf) reduced the risk of death by 30% compared with vemurafenib alone in patients with BRAF-positive advanced melanoma.

The FDA has placed a partial clinical hold on a planned pivotal trial examining an investigational T-cell therapy in patients with myxoid round cell liposarcoma.