News

Supplemental Biologics License Applications (sBLAs) were sent to and accepted by the FDA for a new dosing schedule for nivolumab (Opdivo) across all of the agent's indications as a montherapy, according to Bristol-Myers Squibb (BMS), the manufacturer of the PD-1 inhibitor. 

Russell Berman, MD, discusses ongoing surgical advances in the treatment of melanoma.

Midostaurin (Rydapt) has been recommended for approval by the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) to treat adults with newly diagnosed acute myeloid leukemia (AML) who are FLT3 mutation–positive.

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

Lutathera (lutetium [¹⁷⁷Lu] oxodotreotide) has been recommended for approval by the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) for the treatment of patients with unresectable or metastatic, progressive, well-differentiated (grade 1 and grade 2), somatostatin receptor positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs).

Obinutuzumab (Gazyvaro, EU; Gazyva, US) has been recommended for approval by the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) in the frontline setting for the treatment of patients with follicular lymphoma.

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has given its support on indications for atezolizumab (Tecentriq) in non–small cell lung cancer (NSCLC) and urothelial carcinoma. 

Ipilimumab (Yervoy) has been approved by the FDA for the treatment of patients aged ≥12 years with unresectable or metastatic melanoma, according to Bristol-Myers Squibb (BMS), the manufacturer of the CTLA-4 inhibitor.

MYL-1401O, the trastuzumab (Herceptin) biosimilar manufactured by Mylan Pharmaceuticals, has been recommended for approval by the FDA's Oncologic Drugs Advisory Committee (ODAC) in a 16-0 vote.

Tanios Bekaii-Saab, MD, discusses the the promise of napabucasin in pancreatic cancer.

Neratinib (Nerlynx) has been approved by the FDA for the extended adjuvant treatment of patients with early stage HER2-positive breast cancer following postoperative treatment with trastuzumab (Herceptin). 

Michael B. Atkins, MD, recently shared treatment considerations he would make when treating patients with metastatic renal cell carcinoma (RCC), based on 2 case scenarios.

In a 17-0 vote, the FDA’s Oncologic Drugs Advisory Committee unanimously recommended the approval of ABP-215, a biosimilar for bevacizumab.

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

A supplemental new drug application for dasatinib (Sprycel) for use in children with Philadelphia chromosome-positive chronic phase chronic myeloid leukemia has been accepted by the FDA.

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

Blinatumomab (Blincyto) has been granted a full approval by the FDA as a treatment for adults and children with relapsed/refractory B-cell precursor acute lymphoblastic leukemia, regardless of Philadelphia chromosome status.

Weijing Sun, MD, has been appointed the new Sprint Foundation Professor of Medical Oncology and the director of the Division of Medical Oncology at The University of Kansas School of Medicine and The University of Kansas Cancer Center.

A new drug application (NDA) for abemaciclib has been granted a priority review by the FDA as a treatment for patients with advanced hormone receptor (HR)­­–positive, HER2-negative breast cancer.

A large analysis of data comparing selective internal radiotherapy (SIRT) plus chemotherapy to chemotherapy did not show expected improvements in survival, but an unanticipated benefit was observed with SIRT in patients with metastatic colorectal cancer.

Overall survival was prolonged with treatment with ziv-aflibercept compared to placebo across subgroups of patients with metastatic colorectal cancer with wild-type and mutated <em>RAS, KRAS,</em> and <em>BRAF</em> genes.

In patients with advanced melanoma enrolled in the phase III CheckMate-238 trial,&nbsp;adjuvant nivolumab extended recurrence-free survival compared with adjuvant ipilimumab.

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

A clinical hold has been placed on the phase III KEYNOTE-183 and KEYNOTE-185 pembrolizumab trials and the discontinuation of the lenalidomide/dexamethasone/pembrolizumab arm of the KEYNOTE-023 trial has been ordered by the FDA.

The Breast Cancer Weight Loss Study is looking to identify the relationship between obesity and recurrence in breast cancer through a phone-based weight loss intervention program.

Abemaciclib penetrated brain metastases and had antitumor activity in patients with hormone receptor (HR)-positive, HER2-negative metastatic breast cancer, preliminary evidence suggests.

Rucaparib improved progression-free survival versus placebo as a maintenance treatment for women with&nbsp;platinum-sensitive, high-grade ovarian, fallopian tube, or primary peritoneal cancer,&nbsp;according to results from the phase III ARIEL3 trial.

A recent study is offering insight into&nbsp;the age at which BRCA1/2-positive women are most at risk for deveoping breast and ovarian cancer.

A look back at all the FDA news that happened in the month of June, including in multiple myeloma, hematology, sarcoma, and lung cancer.

Panitumumab has been approved by the FDA in combination with FOLFOX as a frontline treatment for patients with <em>RAS</em> wild-type metastatic colorectal cancer.