The 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.
The 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.
The 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.
The 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.
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The 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.
Patients on Medicaid do not have coverage for routine care on clinical trials. However, the bipartisan Clinical Treatment Act is looking to change that.
The FDA granted a priority review to a supplemental biologics license application for frontline atezolizumab in patients with advanced non-squamous non-small cell lung cancer.
Preliminary durability results of the EV-103 study show that the combination of enfortumab vedotin and pembrolizumab may be a promising option for patients with locally advanced or metastatic urothelial carcinoma.
The 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.
Clinicians should consider patient-related factors, disease-related factors, and prior therapies before deciding on a treatment regimen for patients with relapsed/refractory myeloma.
The 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).
The 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.
The FDA granted a priority review for the biologics license application for lisocabtagene maraleucel (liso-cel), to treat adults with relapsed or refractory large B-cell lymphoma.
Understanding nutritional status and patient cues is crucial in ensuring patients have the proper interventions and treatment plans.
The 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.
Recent years have brought landmark changes to the treatment of advanced lung cancer, but there is still more work to be done.
The agency granted full approval to pemetrexed for injection (Pemfexy), a liquid injection and branded alternative to Alimta, for nonsquamous NSCLC.
Following 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.
Nearly 1 year following the first checkpoint inhibitor approval in advanced triple-negative breast cancer, additional immunotherapeutic agents are poised to enter the field, according to Rita Nanda, MD.
The 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.
Study findings, “changed how we see and treat patients with ovarian cancer,” said one expert.
Oncology Nursing News contributor, Donna Clark, RN, BSN, OCN, passed away on February 4, 2020, leaving a lasting legacy on the world of oncology nursing.
With 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.
There are gaps in knowledge between socioeconomic and education status regarding cancer knowledge, according to a survey conducted in honor of World Cancer Day.
The use of liquid biopsies can expand in the world of oncology, according to Benjamin P. Levy, MD.
Despite 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.
The 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.
