The OncLive® News page includes the latest in clinical oncology news, including breaking regulatory decisions, clinical trial findings, pivotal and practice-changing data published in academic peer-reviewed journals, and more across solid and hematologic malignancies. Regulatory news includes new drug approvals by the FDA and European Union, priority review and breakthrough therapy designations, and orphan drug and fast track statuses.
Encorafenib/Binimetinib-based Triplet Added to NCCN Guidelines for BRAF+ CRC
March 18th 2019The NCCN has updated their clinical practice guidelines for the treatment of patients with colorectal cancer to include the regimen of encorafenib and binimetinib plus EGFR inhibition with either cetuximab or panitumumab as a Category 2a treatment recommendation for patients with BRAF V600E–mutant metastatic colorectal cancer, after failure of 1 or 2 lines of therapy for metastatic disease.
Spectrum Withdraws Application for Eflapegrastim in Chemo-Induced Neutropenia
March 16th 2019Spectrum Pharmaceuticals has voluntarily withdrawn their biologics license application for eflapegrastim, due to the company needing more time to complete the FDA’s request for additional manufacturing-related information.
Key Trials Show Utility of Agents Across Therapeutic Classes in Gastric/GEJ Cancer
March 15th 2019Hope E. Uronis, MD, MHS, sheds light on therapeutic classes in gastric and esophageal cancer and the trials that have demonstrated their utility and refined their applicability across settings, subpopulations, and histologies of gastric/GEJ cancer.
UK Grants EAMS Positive Opinion to Atezolizumab Combo in Frontline TNBC
March 15th 2019The United Kingdom’s Medicines and Healthcare Products Regulatory Agency has granted an Early Access to Medicines Scheme positive scientific opinion to atezolizumab in combination with nab-paclitaxel for patients with unresectable locally advanced or metastatic PD-L1–positive triple-negative breast cancer.
CTC AR-V7 Validated as Predictive Marker of Resistance to AR-Directed Therapy in mCRPC
March 14th 2019AR-V7 protein in circulating tumor cells is a predictive marker of shorter progression-free and overall survival with antiandrogen therapy in patients with metastatic castration-resistant prostate cancer.
Rolling Submission Completed for Daratumumab/Rd in Frontline Transplant-Ineligible Myeloma
March 13th 2019A supplemental biologics license application has been submitted to the FDA for the approval of daratumumab in combination with lenalidomide and dexamethasone for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant.
Nab-Paclitaxel Plus Gemcitabine Misses DFS Endpoint in Pancreatic Cancer
March 13th 2019The adjuvant combination of nab-paclitaxel and gemcitabine was not found to improve disease-free survival compared with gemcitabine alone, as confirmed by independent radiological review, in patients with pancreatic cancer.
Ramucirumab/Erlotinib Combo Improves PFS in Frontline EGFR+ NSCLC
March 12th 2019The combination of ramucirumab and erlotinib significantly improved progression-free survival compared with placebo and erlotinib as a frontline treatment for patients with metastatic EGFR-mutant non–small cell lung cancer, meeting the primary endpoint of the RELAY trial (NCT02411448).
PRRT Moves Needle Forward in NETs, But Unmet Needs Remain
March 12th 2019Michael Morse, MD, FACP, MHS, highlights the importance of peptide receptor radionuclide therapy in the management of patients with neuroendocrine tumors and identifies significant unmet needs that will need to be addressed in order to continue advancement in the space.
FDA Approves Fourth Trastuzumab Biosimilar
March 12th 2019The FDA has granted an approval to PF-05280014 (Trazimera; trastuzumab-qyyp), a trastuzumab biosimilar, to treat patients with HER2-overexpressing breast cancer as well as HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma.
Adjuvant Treatment Strategy Shows Promise in Pancreatic Cancer
March 11th 2019Autumn McRee, MD, highlights promising adjuvant/neoadjuvant strategies under investigation in the pancreatic cancer space and stresses the importance of using a multidisciplinary treatment approach to improve patient outcomes.
Bridging the Knowledge Gap Between Biosimilars and Biologics in Breast Cancer
March 11th 2019Since 2006, the European Medicines Agency has granted marketing authorization for more than 40 biosimilars, and, in less than 4 years, the FDA has approved 17, yet the knowledge gap in the understanding of biosimilarity poses a unique challenge to the agents’ assimilation into clinical practice and possible impact on access and cost savings, experts say.