News

Women with node-positive stage IB-IIB cervical cancer who received systemic chemotherapy post-surgery were at a reduced risk of distant recurrence, according to results from a retrospective study of Japanese women published in the <em>International Journal of Cancer</em>.

Nivolumab (Opdivo) demonstrated clinical activity in women with recurrent/metastatic cervical cancer, and was active to a lesser extent in vaginal and vulvar cancers, according to&nbsp;phase I/II results from CheckMate-358.

Durvalumab (Imfinzi) has been granted a breakthrough therapy designation by the FDA to treat patients with locally-advanced, unresectable non-small cell lung cancer (NSCLC) whose disease has not progressed following platinum-based chemoradiation.

The FDA has granted breakthrough therapy designation to venetoclax (Venclexta) for use in combination with low dose cytarabine (LDAC) in treatment-na&iuml;ve elderly patients with acute myeloid leukemia (AML) who are ineligible for intensive chemotherapy, according to Roche, which is codeveloping the BCL-2 inhibitor with AbbVie.

The use of fulvestrant (Faslodex) to treat estrogen receptor (ER)-positive, locally-advanced or metastatic breast cancer in postmenopausal women not previously treated with endocrine therapy has been approved by the European Commission (EC).

Progression-free survival (PFS) was not improved with frontline durvalumab (Imfinzi), either in combination with tremelimumab or as a single agent,&nbsp;in patients with stage IV metastatic non&ndash;small cell lung cancer (NSCLC), compared with standard platinum-based chemotherapy.

Elizabeth Plimack, MD, recaps recent advances in bladder cancer and discussed the need for diverse approaches to further improve patient outcomes.

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&#39;s indications as a montherapy, according to Bristol-Myers Squibb (BMS), the manufacturer of the PD-1 inhibitor.&nbsp;

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

Midostaurin (Rydapt) has been recommended for approval by the European Medicines Agency&#39;s Committee for Medicinal Products for Human Use (CHMP) to treat adults with newly diagnosed acute myeloid leukemia (AML) who are FLT3 mutation&ndash;positive.

Avelumab (Bavencio) has been recommended for approval by the European Medicines Agency&#39;s&nbsp;Committee for Medicinal Products for Human Use (CHMP)&nbsp;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&rsquo;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&rsquo;s&nbsp;Committee for Medicinal Products for Human Use (CHMP) in the frontline setting for the treatment of patients with follicular lymphoma.

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

Ipilimumab (Yervoy) has been approved by the FDA for the treatment of patients aged &ge;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&#39;s&nbsp;Oncologic Drugs Advisory Committee (ODAC) in a 16-0 vote.

Tanios Bekaii-Saab, MD, discusses the&nbsp;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).&nbsp;

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&rsquo;s Oncologic Drugs Advisory Committee&nbsp;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&rsquo;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)&shy;&shy;&ndash;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.