Jason Harris

Epizyme announced today that the FDA has granted orphan drug designation to its EZH2-inhibitor tazemetostat for the treatment of adults with INI1-negative epithelioid sarcoma.

Dual checkpoint inhibition with nivolumab (Opdivo) plus ipilimumab (Yervoy) induced an objective response rate of 16% in patients with heavily treated, unselected, metastatic sarcoma, according to findings from the phase II ALLIANCE A091401 trial.

Results from a blinded, independent data review confirmed previous results from the CABOSUN trial showing that treatment with cabozantinib (Cabometyx) extended progression-free survival compared with sunitinib (Sutent) for patients with previously untreated, intermediate- or poor-risk advanced renal cell carcinoma.

Seattle Genetics has stopped the phase III CASCADE trial of frontline vadastuximab talirine (SGN-CD33A) for patients with acute myeloid leukemia following a recommendation from an independent data monitoring committee.

The European Commission has approved the rituximab (Rituxan) biosimilar Rixathon (GP2013) to treat patients with follicular lymphoma, diffuse large B-cell lymphoma, and chronic lymphocytic leukemia.

Phase III data from the ARIEL3 trial showed that rucaparib (Rubraca) improved progression-free survival versus placebo as a maintenance treatment for women with platinum-sensitive, high-grade ovarian, fallopian tube, or primary peritoneal cancer.

Lenvatinib (Lenvima) significantly improved overall survival in patients older than 65 years with radioiodine-refractory differentiated thyroid cancer.

The combination of dalantercept plus axitinib (Inlyta) failed to significantly improve progression-free survival in patients with advanced renal cell carcinoma compared with placebo.

Merck announced that it is postponing enrollment in the phase III KEYNOTE-183 and KEYNOTE-185 trials because of deaths in patients with multiple myeloma assigned to pembrolizumab (Keytruda), the company's blockbuster anti-PD-1 therapy.

Astellas Pharma and Pfizer have announced that phase III results from the PROSPER trial of enzalutamide (Xtandi) in men with nonmetastatic castration-resistant prostate cancer will be ready later this year.

Following a second prospectively planned, unblinded analysis, drug manufacturer XBiotech has cancelled the phase III XCITE study of MABp1 (Hutruo; formerly Xilonix) in patients with advanced colorectal cancer.

Results from a phase I/II study demonstrated that enasidenib (AG-221) is well-tolerated and associated with a median overall survival of more than 9 months in patients with IDH2-mutated relapsed/refractory acute myeloid leukemia.

Investigators conducting a small multinational study in Asian patients have concluded that 6 to 9 months of treatment with neoadjuvant imatinib is a promising treatment for patients with large gastric gastrointestinal stromal tumors.

Results from a single-arm, multicenter trial showed that the antibody-drug conjugate sacituzumab govitecan (IMMU-132) was well-tolerated and produced a median duration of response of 6.0 months in previously treated patients with metastatic non–small cell lung cancer.

The FDA’s Oncologic Drugs Advisory Committee has scheduled a public hearing to discuss a biologics license application for tisagenlecleucel-T for patients aged 3 to 25 years with relapsed/refractory B-cell acute lymphoblastic leukemia.

Early results from a Chinese study showed that 33 of 35 patients (94%) with relapsed or refractory multiple myeloma experienced clinical remission after treatment with chimeric antigen receptor T cells targeting B-cell maturation protein.

In patients with ALK-positive non-small cell lung cancer, the second-generation TKI inhibitor alectinib (Alecensa) delayed progression by an additional 15 months compared with the standard-of-care crizotinib (Xalkori).

A new, high-intensity genomic sequencing approach for circulating tumor DNA uncovered at least 1 genetic change in both the tumor DNA and the blood of 89% of patients, demonstrating a high rate of concordance between 2 approaches for detecting molecular aberrations, according to a study presented at the 2017 ASCO Annual Meeting.

Results from a large, phase III trial showed that a single radiation treatment relieves symptoms of spinal cord compression in patients with advanced cancer as effectively as a multifractional course of radiotherapy (RT)

An analysis in locally advanced squamous cell carcinoma of the head and neck showed that weekly low-dose schedules of chemoradiotherapy produce comparable survival outcomes and response rates as the standard 3-weekly schedule.

The FDA has accepted a new drug application from Jazz Pharmaceuticals, granting priority review to the company’s novel CPX-351 injection (Vyxeos) for acute myeloid leukemia.

The UK’s National Institute for Health and Care Excellence will allow first-line use of pembrolizumab (Keytruda) for non–small cell lung cancer as part of the Cancer Drugs Fund.

Physicians treating hepatocellular carcinoma often have to choose between a tyrosine kinase inhibitor (TKI) and immunotherapy but oncologists need better tools to make an informed choice.

Adding ramucirumab (Cyramza) to docetaxel led to a statistically significant improvement in progression-free survival (PFS) versus docetaxel alone in previously treated patients with locally advanced or unresectable or metastatic urothelial carcinoma.

Results from the KEYNOTE-028 study showed that pembrolizumab (Keytruda) was associated with a median duration of response of 6 months and a 6-month progression-free survival rate of 40.4% in women with advanced PD-L1–positive endometrial cancer.

Researchers using cell-of-origin classification connected dual expression of the proteins MYC and BCL2 with poorer survival in patients undergoing chemotherapy for diffuse large B-cell lymphoma.

The FDA’s Oncologic Drugs Committee voted 14-1 to recommend approving a biologics license application for epoetin hospira (Retacrit), an epoetin alfa (Epogen/Procrit) biosimilar manufactured by Hospira.

The FDA has granted a priority review to a supplemental Biologics License Application for pembrolizumab (Keytruda) for the treatment of patients who have undergone at least 2 courses of chemotherapy for recurrent or advanced gastric or gastroesophageal junction adenocarcinoma.

In phase I results from China published in the Journal of Clinical Oncology, oral pyrotinib (HTI-1001) was well-tolerated and showed antitumor activity in women with HER2-positive breast cancer.

Patients with proliferative or mesenchymal ovarian tumors treated with bevacizumab (Avastin) had superior progression-free survival and a trend toward improved overall survival compared with patients with immunoreactive or differentiated tumors.