FDA Approves Pembrolizumab for BCG-Unresponsive, High-Risk Bladder Cancer
January 9th 2020The FDA approved pembrolizumab (Keytruda) for the treatment of patients who are unresponsive to Bacillus Calmette-Guerin (BCG) treatment with high-risk, non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors who are ineligible for or have elected not to undergo cystectomy.
PARP Inhibitor Provides Another Option for Metastatic Pancreatic Cancer
January 8th 2020The metastatic pancreatic cancer paradigm has expanded to include frontline maintenance therapy with the PARP inhibitor olaparib (Lynparza), as it recently received the green light from the FDA with a December 2019 approval.
Itacitinib Misses GVHD Treatment Goal
January 7th 2020The combination of itacitinib and corticosteroids did not induce a statistically significant improvement in overall response rate (ORR) at day 28 compared with placebo plus corticosteroids in patients with treatment-naïve acute graft-versus-host disease (aGVHD).
FDA Accepts BLA for Eflapegrastim for Chemo-Induced Neutropenia
January 4th 2020The FDA has accepted a biologics license application (BLA) to review eflapegrastim (Rolontis) for the management of chemotherapy-induced neutropenia, according to Spectrum Pharmaceuticals, the developer of the novel long-acting granulocyte-colony stimulating factor (G-CSF).
Expert Talks Liquid Biopsies, Molecular Testing in Lung Cancer
January 3rd 2020Not all patients with advanced non–small cell lung cancer (NSCLC) are recommended for genomic testing when treated in a community setting, and are therefore not being appropriately tested for potential molecular drivers of their disease, explained Nathan Pennell, MD, PhD.
FDA Accepts BLA for Sacituzumab Govitecanto Treat TNBC
December 30th 2019The FDA has accepted a biologics license application (BLA) for sacituzumab govitecan as a treatment for patients with metastatic triple-negative breast cancer (TNBC) who have received at least 2 prior therapies for metastatic disease, according to a statement from the company developing the antibody-drug conjugate (ADC), Immunomedics.
After Years of Inactivity, AML Field Moves Forward
December 30th 2019After decades of few advances and stagnant treatment approaches, which mainly comprised 7+3 chemotherapy, the acute myeloid leukemia (AML) paradigm now has several agents approved, and plenty of ongoing trials are exploring other novel therapies alone and in combination, according to Melissa L. Larson, MD.
ALL Field Continues to Progress, With CAR T-Cell and Other Therapies
December 23rd 2019The approval of novel agents, specifically blinatumomab (Blincyto) and CAR T-cell therapy, in the acute lymphoblastic leukemia (ALL) paradigm has led has to expanded options for pediatric, adolescent and young adult (AYA), and adult patients; however, ongoing trials are poised to keep moving the field forward, said Joseph Wynne, MD.
New Agents Are Revamping Prostate Cancer Treatment
December 20th 2019Three pivotal trials demonstrating improved metastasis-free survival (MFS) with 3 different oral antiandrogen agents in combination with androgen deprivation therapy (ADT) have led to FDA approvals that have transformed the treatment paradigm in nonmetastatic castration-resistant prostate cancer (CRPC), said Elisabeth I. Heath, MD, FACP.
FDA Grants Tucatinib Breakthrough Therapy Designation Breast Cancer Subset
December 20th 2019The FDA has granted tucatinib a breakthrough therapy designation for use in combination with trastuzumab (Herceptin) and capecitabine (Xeloda) for the treatment of patients with unresectable locally advanced or metastatic HER2-positive breast cancer, including patients with brain metastases, who had prior trastuzumab, pertuzumab (Perjeta), and ado-trastuzumab emtansine (T-DM1; Kadcyla).
Immunotherapy Brings More Options for Frontline RCC Treatment
December 18th 2019Within approximately 1 year, 3 combination regimens featuring immunotherapy agents were approved by the FDA for the frontline treatment of patients with metastatic renal cell carcinoma (RCC), said Robert J. Motzer, MD.
Breast Cancer Outcomes Can Be Predicted by Residual Cancer Burden
December 16th 2019Residual cancer burden (RCB) after neoadjuvant chemotherapy has been shown to be an accurate long-term predictor of disease recurrence and survival across all breast cancer subtypes, according to data from a large meta-analysis presented at the 2019 San Antonio Breast Cancer Symposium.