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.
Neoadjuvant Durvalumab Is Promising for TNBC Treatment
December 14th 2019A durvalumab (Imfinzi)-based neoadjuvant regimen induced a pathologic complete response (pCR) rate of 44% in patients with triple-negative breast cancer (TNBC), according to results of a phase I/II study presented in a poster at the 2019 San Antonio Breast Cancer Symposium.
Palbociclib Shows OS Benefit in Frontline HR+/HER2- Breast Cancer
December 13th 2019Real-world clinical practice results for frontline palbociclib (Ibrance) indicate that the positive progression-free survival (PFS) data previously reported with the CDK4/6 inhibitor in the pivotal PALOMA-2 trial would likely translate to an overall survival (OS) benefit in patients with HR-positive/HER2-negative metastatic breast cancer.
Reducing Transfusion Burden in Patients With Beta-Thalassemia
December 11th 2019A majority of adult patients with β-thalassemia who require regular red blood cell (RBC) transfusions experienced clinically meaningful and durable transfusion burden reduction associated with luspatercept (Reblozyl) in the phase III BELIEVE trial.
Drug Combo Shows 100% ORR in Non-Hodgkin Lymphoma Subset
December 10th 2019The combination of lenalidomide (Revlimid) and obinutuzumab (Gazyva) elicited a 100% overall response rate (ORR) in patients with relapsed indolent non-Hodgkin lymphoma (NHL) that was refractory to rituximab (Rituxan), according to findings of a single-arm, phase I/II trial presented at the 2019 ASH Annual Meeting.
Early Steroid Use Reduces Cytokine Release Syndrome Risk With Axi-Cel Treatment
December 9th 2019Steroid use while cytokine release syndrome (CRS) and neurologic toxicities are at grade 1, instead of waiting until grade 3, reduces the rate of CAR T-cell treatment–related CRS and neurologic events.
Overcoming AI Resistance in ESR1-Mutant Breast Cancer
December 7th 2019Resistance to aromatase inhibitors (AIs) is a growing concern in patients with advanced hormone receptor (HR)–positive, HER2-negative breast cancer, said Hope S. Rugo, MD, FASCO, who added that although fulvestrant (Faslodex) has shown some activity in patients who develop ESR1 mutations, more effective treatment options are needed.
FDA Grants Breakthrough Therapy Designation for GVHD Prevention Drug
December 4th 2019The US Food and Drug Administration (FDA) has granted breakthrough therapy designation to abatacept (Orencia) to prevent moderate or severe acute graft-versus-host disease (GvHD) in patients who underwent a hematopoietic stem cell transplant and are not related to their donors, according to Bristol-Myers Squibb, the manufacturer of the drug.
FDA Approves Frontline Atezolizumab Plus Carboplatin/Nab-Paclitaxel for Lung Cancer Subset
December 4th 2019The FDA has approved atezolizumab (Tecentriq) in combination with carboplatin and nab-paclitaxel (Abraxane) for the first-line treatment of adult patients with metastatic nonsquamous non–small cell lung cancer (NSCLC) who do not harbor EGFR or ALK molecular aberrations.
FDA Grants Pembrolizumab Priority Review for High-Risk Bladder Cancer
December 2nd 2019The FDA has granted a priority review designation to pembrolizumab (Keytruda) for the treatment of patients with Bacillus Calmette-Guerin (BCG)–unresponsive, high-risk, non-muscle invasive bladder cancer (NMIBC) with carcinoma in-situ (CIS) with or without papillary tumors who are ineligible for or chose to not undergo cystectomy.
FDA Grants Durvalumab Priority Review for Small Cell Lung Cancer Treatment
December 2nd 2019The FDA has granted a priority review designation to a supplemental Biologics License Application (sBLA) for durvalumab (Imfinzi) for the frontline treatment of patients with extensive-stage small cell lung cancer (ES-SCLC).1