The FDA has granted enfortumab vedotin-ejfv both a regular approval and a new indication expansion for the treatment of adult patients with locally advanced or metastatic urothelial cancer who are ineligible for cisplatin-containing chemotherapy and have previously received 1 or more prior lines of therapy.
The trial has successfully enrolled 17 patients with clear cell renal cell carcinoma and has reported that the drug is well tolerated at doses of up to 525 mg weekly.
The ASCO-COA Oncology Medical Home standards offer a roadmap for comprehensive high-quality, patient-centered cancer care delivery.
Despite the encouraging progression-free survival findings, data on overall survival resulted in a partial clinical hold instituted by the FDA.
Margetuximab-cmkb (Margenza) was approved in December 2020 in combination with chemotherapy for the treatment of adult patients with metastatic HER2-positive breast cancer who have previously received 2 or more anti-HER2 regimens, at least one of which for metastatic disease.
Results from the APOLLO trial showed a significant 37% reduction in the risk of progression or death, compared to pomalidomide and dexamethasone alone in patients with multiple myeloma.
Nivolumab (Opdivo; Bristol Myers Squibb) is FDA approved for 11 cancer indications, with the most recent approval for use in combination with certain chemotherapy for the initial treatment of gastric cancer.
The FDA granted accelerated approval in 2019 to enfortumab vedotin-ejfv for the treatment of adult patients with locally advanced or metastatic urothelial cancer who have previously received a PD-1/L1 inhibitor and a platinum-containing chemotherapy before or after surgery, or in a locally advanced or metastatic urothelial cancer setting.
Milind Javle, PhD, professor of Gastrointestinal Medical Oncology at the University of Texas MD Anderson Cancer Center, discussed the importance of the FDA’s expedited approval process for infigratinib in the treatment of previously treated locally advanced or metastatic cholangiocarcinoma.
The data show that the maximum tolerated dose of rigosertib in combination with nivolumab was not reached in the 3 cohorts of the trial’s dose-escalation phase in patients with advanced KRAS-positive metastatic lung adenocarcinoma.
In an interview with Pharmacy Times® and Directions in Oncology Pharmacy®, Abizer Gaslightwala, vice president and head of the U.S. Hematology and Oncology division at Jazz Pharmaceuticals discusses the company’s new digital resource, Nothing Small About It.
Survival for patients with glioblastoma tumors is poor, with close to 75% of patients dying within 2 years of diagnosis and 95% dying within 5 years.
Milind Javle, PhD, professor of Gastrointestinal Medical Oncology at the University of Texas MD Anderson Cancer Center, discussed the importance of the FDA’s expedited approval process for infigratinib in the treatment of previously treated locally advanced or metastatic cholangiocarcinoma.
Milind Javle, PhD, professor of Gastrointestinal Medical Oncology at the University of Texas MD Anderson Cancer Center, discussed how the US FDA evaluated the application for infigratinib to expedite the approval process for treatment of previously treated locally advanced or metastatic cholangiocarcinoma.
The drug is approved for patients after 4 or more failed lines of therapy, although many patients in clinical trials had received 7 or more prior lines of therapy.
New research presented at the ESMO World Congress on Gastrointestinal Cancer suggests the use of antibiotics may increase the risk of colon cancer, especially in individuals under age 50 years.
The 5-year overall survival was 18% in the CPX-351 group compared to 8% in the standard chemotherapy group.
CEL-SCI Corporation plans to file for FDA approval in patients with advanced primary squamous cell carcinoma of the head and neck based on these trial results.
Milind Javle, PhD, professor of Gastrointestinal Medical Oncology at the University of Texas MD Anderson Cancer Center, discussed the dosing and treatment cycle during the trial assessing infigratinib for the treatment of previously treated locally advanced or metastatic cholangiocarcinoma.
The approval is based on results from the phase 2 KEYNOTE-629 trial, which found an objective response rate of 50% in adults with recurrent, metastatic, or locally advanced cutaneous squamous cell carcinoma.
Two studies by the University of Colorado Cancer Center provided an analysis for the theory of adaptive oncogenesis.
Pharmacists’ vast health care knowledge and community accessibility makes them ideal patient liaisons.
Mikhail Kosiborod, MD, cardiologist and vice president of research at Saint Luke's Health in Kansas City, discussed how the phase 3 DARE-19 trial was conducted to assess dapagliflozin in patients with type 2 diabetes hospitalized with COVID-19.
Milind Javle, PhD, professor of Gastrointestinal Medical Oncology at the University of Texas MD Anderson Cancer Center, discussed the safety profile of infigratinib for the treatment of patients with previously treated locally advanced or metastatic cholangiocarcinoma.
Milind Javle, PhD, professor of Gastrointestinal Medical Oncology at the University of Texas MD Anderson Cancer Center, discusses the eligibility requirements for patients included in the phase 2 trial results that led to the FDA approval of infigratinib.
Factors that may have contributed to the screening declines include site closures and temporary pausing of services.
The current study analyzed human tumor samples from 6 cancer types: liver, melanoma, colorectal, non-small lung, head and neck, and breast cancer.
Sacituzumab govitecan is approved for the treatment of patients with unresectable locally advanced or metastatic triple-negative breast cancer who have received 2 more prior systemic therapies.
The clinical benefit rate was observed in 16.7% of patients in the balixafortide arm and in 19.6% of patients in the eribulin monotherapy arm.
Milind Javle, PhD, professor of Gastrointestinal Medical Oncology at the University of Texas MD Anderson Cancer Center, discussed the findings of the phase 2 trial assessing infigratinib for treatment of previously treated locally advanced or metastatic cholangiocarcinoma harboring an FGFR2 fusion or rearrangement.
