News
FDA Approves Neratinib Combination for HER2+ Breast Cancer
February 26th 2020The FDA has approved a supplemental new drug application (sNDA) for neratinib (Nerlynx) in combination with capecitabine (Xeloda) for the treatment of adult patients with advanced or metastatic HER2-positive breast cancer who have received ≥2 prior anti–HER2-based regimens in the metastatic setting.
FDA Accepts BLA for Pertuzumab/Trastuzumab Combo for HER2+ Breast Cancer
February 26th 2020The FDA has accepted a Biologics License Application (BLA) for a fixed-dose combination (FDC) of pertuzumab (Perjeta) and trastuzumab (Herceptin) with hyaluronidase, administered by subcutaneous (SC) injection in combination with intravenous (IV) chemotherapy, for the treatment of eligible patients with HER2-positive breast cancer.
FDA Accepts Niraparib Application for Frontline Maintenance Ovarian Cancer Treatment
February 25th 2020The FDA has accepted a supplemental New Drug Application (sNDA) for niraparib (Zejula) for use as a frontline maintenance treatment for women with advanced ovarian cancer who responded to platinum-based chemotherapy regardless of biomarker status.
Personalized Treatments, HER2-Directed Drugs Are Changing the Breast Cancer Space
February 23rd 2020The fields of early-stage hormone receptor (HR)–positive and metastatic HER2-positive breast cancer have made great strides in recent years, said Neelima Denduluri, MD, and such progress could be attributed to the emergence of tailored treatment strategies and the use of HER2-directed agents, respectively.
FDA Grants Priority Review to Selinexor for DLBCL Treatment
February 21st 2020The FDA has granted a priority review designation to a supplemental new drug application (sNDA) for selinexor (Xpovio) as a treatment for adult patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL), not otherwise specified, who have received ≥2 prior therapies.
FDA Grants Priority Review to Lurbinectedin to Treat SCLC
February 17th 2020The FDA has granted a priority review designation to a new drug application (NDA) for lurbinectedin as a treatment for patients with small cell lung cancer (SCLC) who have progressed following platinum-containing therapy.
Ilixadencel Added to Sunitinib May Improve RCC Outcomes
February 15th 2020The addition of the off-the-shelf cancer immune primer ilixadencel to sunitinib (Sutent) trended toward a benefit in overall survival (OS) compared with sunitinib alone as a first-line treatment for patients with newly diagnosed metastatic renal cell carcinoma (RCC).
Immunotherapy Plus Chemo Improves Metastatic TNBC Outcomes
February 14th 2020The frontline combination of pembrolizumab (Keytruda) and chemotherapy significantly improved progression-free survival (PFS) compared with chemotherapy alone in patients with metastatic triple-negative breast cancer (TNBC) whose tumors expressed PD-L1 (combined positive score [CPS] ≥10), meeting one of the dual primary endpoints of the phase III KEYNOTE-355 trial.
FDA Grants Priority Review to KTE-X19 for Treatment of Mantle Cell Lymphoma
February 11th 2020The biologic license application is supported by data from the phase II ZUMA-2 trial, which is currently assessing the CAR T-cell therapy for the treatment of adult patients with relapsed or refractory mantle cell lymphoma.
Surgery Refinements Named ASCO's Advance of the Year
February 9th 2020Following significant progress made in the development of novel systemic therapies for patients with cancer, the role of surgery in oncology continues to evolve. To this end, ASCO has selected the refinement of surgical treatment of cancer as its Advance of the Year.
FDA Extends Review Period for Avapritinib to Treat GIST
February 8th 2020The FDA has extended the Prescription Drug User Fee Act deadline for a new drug application (NDA) for avapritinib (Ayvakit) as a treatment for adult patients with fourth-line gastrointestinal stromal tumor (GIST). The deadline, which was initially February 14, 2020, has been extended by 3 months to May 14, 2020, according to BluePrint Medicines, the developer of avapritinib.
Increasing Prostate Cancer Screening Takes a Team Approach
February 6th 2020With the advent of targeted therapy, understanding the genetic components of a patient's disease has become critical in oncology. As the role of genetic testing in prostate cancer has grown, the field is also overcoming hurdles with making it more widespread, said Thomas J. Polascik, MD.
Unmet Needs Remain in TNBC Treatment
February 3rd 2020Despite the emergence of PARP inhibitors, antibody-drug conjugates (ADCs), and immunotherapy in the treatment of patients with triple-negative breast cancer (TNBC), more work is needed to propel further progress, according to Kevin Kalinsky, MD, MS.
Biomarkers Predict Osteosarcoma Treatment Response
February 2nd 2020The presence of the proteins p16 and p21 has shown to be predictive of treatment response in patients with osteosarcoma, a disease that previously had no identified biomarkers to indicate whether or not patients would benefit from therapy, explained C. Parker Gibbs, MD.
