All Oncology News

Spectrum Pharmaceuticals has voluntarily withdrawn their biologics license application for eflapegrastim, due to the company needing more time to complete the FDA’s request for additional manufacturing-related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.

The FDA has added 3 months to the review period for a new drug application for selinexor for the treatment of patients with penta-refractory multiple myeloma, making the new action date July 6, 2019.

Sergio A. Giralt, MD, discusses recent data with allogeneic hematopoietic stem cell therapy and why this long-standing modality remains an integral part of treatment for patients with relapsed myeloma.

Hope 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.

Michael A. Morse, MD, FACP, MHS, highlights the latest ongoing research in hepatocellular carcinoma and predicts what future treatment might look like in this field.

The 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.

The European Commission has approved pembrolizumab in combination with carboplatin and either paclitaxel or nab-paclitaxel for the frontline treatment of patients with metastatic squamous non–small cell lung cancer.

Given the poor prognosis of pancreatic cancer and the steady stream of negative phase III trials, clinicians are facing an uphill battle in the treatment of patients with metastatic pancreatic cancer.

AR-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.

Nilofer Saba Azad, MD, discusses data from 3 recent pivotal trials have influenced practice and/or warrant consideration when treating patients with localized pancreatic cancer.

A 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.

Jonathan R. Strosberg, MD, sheds light on the latest developments made in the complex treatment paradigm of gastroenteropancreatic neuroendocrine tumors.

The 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.

National Cancer Institute director Norman (Ned) E. Sharpless, MD, has been named as acting commissioner of the FDA once Scott Gottlieb, MD, leaves the regulatory agency in April 2019.

The 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).

Naiyer A. Rizvi, MD, highlights the progress made with immunotherapy in patients with NSCLC and shed light on where further research needs to go to move the needle forward.

Michael 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.

The 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.

Matthew S. Davids, MD, MMSc, discusses methods for choosing between frontline therapies for patients with newly diagnosed chronic lymphocytic leukemia and highlights anticipated research in the field.

Autumn 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.

Combining lenvatinib and pembrolizumab led to a 25% overall response rate in patients with urothelial carcinoma and was associated with a manageable safety profile.

Michael S. Lee, MD, sheds light on the treatment options available in the metastatic colorectal cancer space and highlights strategies poised to improve patient outcomes.

Noopur Raje, MD, discusses the current treatment landscape of multiple myeloma, with a specific focus on available triplet regimens and the recent data with chimeric antigen receptor T-cell therapy.

Since 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.

The treatment of patients with advanced HER2-positive breast cancer could be reshaped in the next several years as clinical trials of several exciting new drugs begin to yield results.

Niharika B. Mettu, MD, PhD, discusses frontline approaches, maintenance therapy, sequencing strategies, and emerging agents for patients with newly diagnosed metastatic pancreatic cancer.

John Strickler, MD, highlights important data in the metastatic colorectal cancer space and challenges that remain for oncologists working in the field.

The FDA has approved the frontline combination of atezolizumab plus nab-paclitaxel for patients with unresectable locally advanced or metastatic PD-L1–positive triple-negative breast cancer.

The European Commission has approved and granted marketing authorization to the frontline combination of atezolizumab, bevacizumab, paclitaxel, and carboplatin for the first-line treatment of patients with metastatic, nonsquamous non–small cell lung cancer.

Richard M. Stone, MD, discusses the therapeutic landscape for elderly patients with acute myeloid leukemia.