Jason Harris

Pembrolizumab (Keytruda) did not meet the primary endpoint of overall survival in the phase III KEYNOTE-040 trial in patients with previously-treated recurrent or metastatic head and neck squamous cell carcinoma.

Systemic chemotherapy administered post-surgery reduced the risk for distant recurrence in women with node-positive stage IB-IIB cervical cancer.

The European Medicines Agency’s Committee for Medicinal Products for Human Use has taken a positive position on indications for atezolizumab in non­-small cell lung cancer and urothelial carcinoma.

The European Medicines Agency's Committee for Medicinal Products for Human Use has recommended approval of avelumab (Bavencio) for adults with metastatic Merkel cell carcinoma, according to Pfizer and Merck, the codevelopers of the PD-L1 inhibitor.

The European Medicines Agency's Committee for Medicinal Products for Human Use has recommended approval of midostaurin to treat adults with newly diagnosed acute myeloid leukemia who are FLT3 mutation-positive.

Cediranib was associated with significantly reduced tumor burden and superior progression-free survival compared with placebo in patients with alveolar soft part sarcoma.

Results now published in the New England Journal of Medicine show that nivolumab (Opdivo) was not superior for progression-free survival compared with chemotherapy as a first-line treatment for patients with NSCLC.

Nivolumab demonstrated clinical activity in women with recurrent/metastatic cervical cancer, and was active to a lesser extent in vaginal and vulvar cancers.

Patients with intermediate- or high-risk gastrointestinal stromal tumors were less likely to experience recurrence after 5 years of treatment with imatinib (Gleevec), as determined by results from the phase II PERSIST-5 trial.

Five-year follow-up from the BRIGHT study confirmed that bendamustine plus rituximab is associated with improved progression-free survival compared with R-CHOP or R-CVP in patients with mantle cell lymphoma or indolent non-Hodgkin lymphoma.

Amgen has announced that it has submitted supplemental New Drug Applications (sNDA) in the United States and Europe based on data from 2 phase III studies showing carfilzomib (Kyprolis) improves overall survival (OS) for patients with relapsed/refractory multiple myeloma.

The FDA’s Oncologic Drugs Advisory Committee voted 16-0 to recommend approval to MYL-1401O, the trastuzumab (Herceptin) biosimilar manufactured by Mylan Pharmaceuticals.

The FDA’s Oncologic Drugs Advisory Committee voted 17-0 to recommend approval for ABP-215, a biosimilar for bevacizumab (Avastin) to treat a range of solid tumors.

Following treatment with single-agent nivolumab (Opdivo), patients with head and neck squamous cell carcinoma saw improved or stable quality of life scores.

Oncologic Drugs Advisory Committee voted 10-0 today to recommend approval of a biologics license application for tisagenlecleucel (CTL019) for the treatment of patients aged 25 or younger with relapsed/refractory B-cell acute lymphoblastic leukemia.

Phase III results from the RAY trial showed that patients with mantle cell lymphoma treated with ibrutinib (Imbruvica) had superior quality of life compared with patients treated with temsirolimus.

Patients with metastatic renal cell carcinoma had an objective response rate of 40% and a 2-year overall survival rate of nearly 70% with the immune checkpoint combination of ipilimumab (Yervoy) and nivolumab (Opdivo), in phase I results from CheckMate-016.

The FDA’s Oncologic Drugs Advisory Committee voted 6-1 in favor of approving gemtuzumab ozogamicin (Mylotarg) in combination with daunorubicin and cytarabine for the treatment of patients with newly-diagnosed CD33-positive acute myeloid leukemia.

The FDA has accepted a supplemental new drug application for dasatinib (Sprycel) for use in children with Philadelphia chromosome-positive chronic phase chronic myeloid leukemia (CP Ph+ CML).

The triplet combination of HER2-targeted therapy and an aromatase inhibitor improved progression-free survival by more than 5 months compared with the combination of trastuzumab (Herceptin) and an aromatase inhibitor in patients with HER2+/HR+ breast cancer.

The FDA has placed a clinical hold on the phase III KEYNOTE-183 and KEYNOTE-185 pembrolizumab (Keytruda) trials and ordered the discontinuation of the lenalidomide/dexamethasone/pembrolizumab arm of the KEYNOTE-023 trial in patients with multiple myeloma.

Adjuvant nivolumab (Opdivo) extended recurrence-free survival compared with adjuvant ipilimumab (Yervoy) in patients with advanced melanoma enrolled in the phase III CheckMate-238 trial.

The European Union has approved the use of ceritinib for the first-line treatment of patients with ALK-positive advanced non­–small cell lung cancer.

Frontline brentuximab vedotin (Adcetris) was associated with improved progression-free survival compared with standard chemotherapy in patients with advanced classical Hodgkin lymphoma, according to results from the phase III ECHELON-1 clinical trial.

Updated phase II results from the KEYNOTE-052 trial showed that first-line treatment with pembrolizumab (Keytruda) produced a long-lasting response for patients with cisplatin-ineligible advanced urothelial cancer.

The Committee for Medicinal Products for Human Use has adopted a positive opinion recommending marketing authorization of tivozanib for adult patients with advanced renal cell carcinoma.

The FDA has rejected Hospira's a biologics license application for the epoetin alfa biosimilar, epoetin hospira, citing manufacturing concerns at the company's fill-finish facility in McPherson, Kansas.

The Committee for Medicinal Products for Human Use, a part of the European Medicines Agency, recommended approval of ribociclib (Kisqali) for use in combination with an aromatase inhibitor as a first-line treatment for postmenopausal women with hormone receptor-positive /HER2-negative locally advanced or metastatic breast cancer.

Aldoxorubicin was associated with superior progression-free survival compared with standard chemotherapy regimens and may be a viable treatment alternative for some patients with relapsed or refractory soft tissue sarcomas, according to results from a phase III international study.

The FDA approved the combination of dabrafenib and trametinib for patients with BRAF V600–positive advanced or metastatic non–small cell lung cancer.