Jason M Broderick

In a combined decision, members of the FDA's Oncologic Drugs Advisory Committee and Cellular, Tissue and Gene Therapies Advisory Committee (CTGTAC) voted 22-1 to recommend approval of T-VEC.

The FDA has assigned a priority review designation to Opdivo (nivolumab) as a treatment for previously untreated patients with unresectable or metastatic melanoma.

Frontline immunotherapy with Opdivo (nivolumab) plus Yervoy (ipilimumab) delayed disease progression by 60 percent compared with Yervoy alone in patients with advanced melanoma.

Keytruda (pembrolizumab) had an overall response rate (ORR) of 45.2 percent among a cohort of patients with high PD-L1-expressing non–small cell lung cancer in the early phase KEYNOTE-001 trial.

The Food and Drug Administration has approved the anti–PD-1 agent Opdivo (nivolumab) for the treatment of patients with advanced squamous non-small cell lung cancer (NSCLC). The approval comes three months ahead of the FDA's scheduled decision date.

The Food and Drug Administration (FDA) has granted a priority review to Opdivo for use in patients with previously treated, advanced, squamous non-small cell lung cancer (NSCLC). A decision will be made by June 22, 2015.

The FDA has granted a priority review to the MEK inhibitor cobimetinib for use in combination with the BRAF inhibitor Zelboraf to treat patients with BRAF V600–positive advanced melanoma.

The FDA has approved Revlimid plus dexamethasone in newly diagnosed patients with multiple myeloma based on findings from the phase 3 FIRST trial.

The FDA has granted approval to Lenvima (lenvatinib) as a treatment for patients with progressive, radioactive iodine (RAI)-refractory differentiated thyroid cancer (DTC), based on findings from the phase 3 SELECT trial.

With a deadline of April 14, the FDA will soon make its final approval decision on lenvatinib as a treatment for patients with progressive, radioactive iodine (RAI)-refractory differentiated thyroid cancer (DTC).

A phase 3 study of Gazyva in indolent non-Hodgkin lymphoma has been stopped early after an interim analysis found the drug improved progression-free survival.

The Food and Drug Administration (FDA) granted a priority review to Yondelis to treat patients with the disease, including liposarcoma and leiomyosarcoma subtypes, who have previously received chemotherapy that included an anthracycline. The FDA will make its final approval decision within six months.

The PD-L1 inhibitor MPDL3280A has received a breakthrough therapy designation from the FDA for PD-L1–positive non–small cell lung cancer (NSCLC) that has progressed on prior therapy.

The Food and Drug Administration granted a Fast Track Designation to CPX-351 for the treatment of elderly patients with relapsed acute myeloid leukemia (AML).

Women with hormone receptor-positive breast cancer who remained premenopausal after receiving chemotherapy had a lower risk of disease recurrence when adding ovarian suppression to adjuvant Aromasin, according to results from the phase 3 SOFT trial.

Patients with metastatic colorectal cancer treated with Cyramza and standard FOLFIRI lived a median of 1.6 months longer than patients treated with FOLFIRI alone, according to results from the phase 3 RAISE trial.

A phase 3 trial of Opdivo (nivolumab) in patients with non-small cell lung cancer was stopped early after results determined that the drug improves survival.

A Food and Drug Administration advisory committee unanimously recommended approval of EP2006, a biosimilar version of Neupogen (filgrastim).