The OncLive® News page includes the latest in clinical oncology news, including breaking regulatory decisions, clinical trial findings, pivotal and practice-changing data published in academic peer-reviewed journals, and more across solid and hematologic malignancies. Regulatory news includes new drug approvals by the FDA and European Union, priority review and breakthrough therapy designations, and orphan drug and fast track statuses.
Germline Testing: Exploring How DNA Impacts Cancer Risk and Treatment
December 1st 2021Researchers from Rutgers Cancer Institute of New Jersey and Dana-Farber Cancer Institute developed and evaluated a computational pipeline that utilizes information commonly provided in tumor sequencing assays to predict the origin of detected DNA alterations.
Oncology Drug Regulation Faces an Uncertain Future
December 1st 2021Maurie Markman, MD, discusses how agency leaders should be encouraged to improve regulatory science, include a patient’s perspective in approval decisions, reduce unnecessary bureaucracy and costs associated with the conduct of trials, and accelerate the overall review process for drug approval.
Retifanlimab Shows Promising Antitumor Activity in Advanced Endometrial Cancer
December 1st 2021Retifanlimab demonstrated encouraging antitumor activity with favorable tolerability in patients with recurrent microsatellite instability–high or mismatch repair deficient endometrial cancer, according to data from the phase 1 POD1UM-101 trial.
FDA Extends Review Period for Pacritinib in Myelofibrosis With Severe Thrombocytopenia
November 30th 2021The FDA has extended the review period for the new drug application for pacritinib as a treatment for adult patients with intermediate- or high-risk primary or secondary (post-polycythemia vera or post-essential thrombocythemia) myelofibrosis and severe thrombocytopenia with a baseline platelet count of 50 x 109/L.
Niraparib Demonstrates PFS Benefit in Chinese Population With Advanced Ovarian Cancer
November 30th 2021First-line maintenance treatment with the PARP inhibitor niraparib yielded a clinically meaningful and statistically significant improvement in progression-free survival vs placebo in Chinese patients with platinum-responsive advanced ovarian cancer, regardless of biomarker status, according to data from the phase 3 PRIME trial.
Frontline Pembrolizumab Plus Chemotherapy Approved in Japan for Esophageal Carcinoma
November 30th 2021The Japan Pharmaceuticals and Medical Devices Agency has approved the PD-1 inhibitor pembrolizumab for frontline use in combination with 5-fluorouracil plus cisplatin chemotherapy in patients with radically unresectable, advanced, or recurrent esophageal carcinoma.
Pembrolizumab/Axitinib Improves Outcomes in Japanese mRCC Subgroup
November 30th 2021The combination of pembrolizumab and axitinib demonstrated comparable activity and safety vs sunitinib in Japanese patients vs the global population of patients with newly diagnosed metastatic renal cell carcinoma enrolled in the phase 3 KEYNOTE-426 trial.
FDA Grants Priority Review to Olaparib for BRCA+, High-Risk Early Breast Cancer
November 30th 2021The FDA has granted a priority review designation to a supplemental new drug application for the use of olaparib as adjuvant therapy in patients with BRCA-mutated, high-risk, HER2-negative early breast cancer who have previously received neoadjuvant or adjuvant chemotherapy.
Abiraterone/Docetaxel Combo Associated With Improved QOL Vs Docetaxel in mHSPC
November 30th 2021Patients with locally advanced or metastatic hormone-sensitive prostate cancer who received docetaxel and abiraterone acetate plus prednisone or prednisolone and standard of care androgen deprivation therapy had superior patient-reported quality of life compared with patients who received docetaxel plus ADT, although the improvement narrowly missed the predefined value for clinical significance.
European Commission Approves Pembrolizumab/Lenvatinib for Advanced or Recurrent Endometrial Cancer
November 29th 2021The European Commission has granted an approval to the combination of pembrolizumab and lenvatinib for the treatment of patients with advanced or recurrent endometrial carcinoma who have disease progression on or following prior platinum-containing therapy in any setting and who are not eligible for curative surgery or radiation.
Experts Review Key Data From ESMO Congress 2021
November 29th 2021Several leading experts discussed a variety of tumor types set to influence the next wave of investigative directions and change the standard of care for patients in abstracts at the European Society for Medical Oncology Congress 2021.
Novel Therapies Propel the Paradigms of Breast and Gynecologic Cancers Forward
November 28th 2021Panelists discuss the latest advances in targeting HER2-positive breast cancer, the rapidly evolving landscape of triple-negative breast cancer, the role of maintenance therapy in ovarian cancer, and recent updates in the treatment of patients with endometrial and cervical cancers.
Investigators Set Their Sights on Novel Targets in Genitourinary Malignancies
November 27th 2021Manojkumar Bupathi, MD, MS, shares the main highlights from the meeting, which centered on frontline, second, and later-line treatment of metastatic urothelial carcinoma and metastatic renal cell carcinoma.
Frontline Cabozantinib Plus Atezolizumab Shows Favorable Survival in Advanced HCC
November 26th 2021The combination of cabozantinib and atezolizumab led to a statistically significant improvement in progression-free survival and a numerical improvement in overall survival vs sorafenib as frontline treatment in patients with advanced hepatocellular carcinoma, according to findings from the first planned analysis of the phase 3 COSMIC-312 trial.
FDA Greenlights Maribavir for Select Post-Transplant Recipients With CMV
November 24th 2021The FDA has approved maribavir for the treatment of adult and pediatric patients aged 12 years and older weighing at least 35 kg who have post-transplant cytomegalovirus infection that does not respond to available antiviral treatment.
Practice-Changing and Reaffirming Data Set Up an Exciting Future in Melanoma
November 24th 2021Positive data readouts from studies such as the phase 2/3 RELATIVITY-047 trial with relatlimab and nivolumab, and the phase 3 KEYNOTE-716 trial with pembrolizumab, cemented 2021 as a banner year for the treatment of patients with melanoma, across various stages and subtypes.
Home Infusion Trend Stirs Debate
November 24th 2021The COVID-19 pandemic spurred the launching or expansion of in-home cancer therapy infusion programs at several oncology centers around the United States, drawing a surge of interest throughout the field as well as opposition from oncologists who are concerned about the implications for patient safety and the potential impact on community practices that provide in-house infusion services.