All Oncology News

A biologics license application has been submitted to the FDA for the approval of F-627 as a treatment option for patients with breast cancer who have chemotherapy-induced neutropenia.

The rolling submission of a new drug application has been completed and submitted to the FDA to support the approval of pacritinib as a treatment for patients with myelofibrosis and severe thrombocytopenia defined as having platelet counts less than 50 x 109/L.

The first-in-class N-terminal domain androgen receptor inhibitor EPI-7386 is being examined in combination with enzalutamide in patients with metastatic castration-resistant prostate cancer as part of a phase 1/2 trial.

A prospective, multicenter, observational USOPTIVAL study has been initiated in the United States to examine an investigational cell-free DNA blood test to detect advanced adenoma and colorectal cancer.

The European Commission has approved the combination of cabozantinib plus nivolumab for use as a frontline treatment in patients with advanced renal cell carcinoma.

The Canada Foundation for Innovation has awarded C$5,187,685 to the Canadian Cancer Trials Group at Queen’s University in Kingston, Ontario, Canada, to fund the infrastructure for a new research platform to coordinate the development of new cancer cell therapies.

Because the current standard-of-care modalities have significant limitations, there has been a great interest in pursuing immunotherapeutic strategies for glioblastoma.

From delayed diagnoses, to the emergence of telemedicine, to managing the increased emotional burden experienced by patients and healthcare professionals alike, the community has been forced to approach cancer care in ways they never had before in light of the COVID-19 pandemic.

The FDA has approved a revised label for daunorubicin/cytarabine (Vyxeos) to include the treatment of pediatric patients aged 1 year and older with newly diagnosed, therapy-related acute myeloid leukemia (AML) or AML with myelodysplasia-related changes.

Robert Wenham, MD, MS, FACOG, FACS, discusses future directions with antibody-drug conjugates in the treatment of patients with ovarian cancer.

The FDA has granted a fast track designation for annamycin as a treatment for patients with soft tissue sarcoma lung metastases.

Narjust Duma, MD, has been named as the new associate director of the Cancer Care Equity Program at the Dana-Farber Cancer Institute, as well as an assistant professor of medicine at Harvard Medical School.

The National Comprehensive Cancer Network has updated its Clinical Practice Guidelines to include tivozanib as a recommended regimen for subsequent therapy in patients with clear cell renal cell carcinoma.

Gilteritinib was found to result in a significant improvement in overall survival when used in patients with FLT3-mutated, relapsed/refractory acute myeloid leukemia, meeting the primary end point of the confirmatory phase 3 COMMODORE trial in China.

The European Medicines Agency’s Committee for Medicinal Products for Human Use has adopted a positive opinion in favor of recommending that the label for pembrolizumab in Europe be updated to include findings from the phase 3 KEYNOTE-361 trial.

The European Medicines Agency’s Committee for Medicinal Products for Human Use has adopted a positive opinion to recommend an additional indication of enzalutamide for the treatment of adult patients with metastatic hormone-sensitive prostate cancer.

Investigators are seeking to determine the optimal protocol for monitoring patients with pancreatic cysts to better identify neoplasms that are more likely to become malignant.

The National Comprehensive Cancer Network guidelines for the management of frontline and relapsed/refractory multiple myeloma were updated to incorporate novel agents and combination strategies, providing a wide range of category 1 recommended therapies for patients.

Faculty from the Miami Breast Cancer Conference® discuss how to apply the RxPONDER data to clinical practice.

Lewis Au, MBBS, BMedSci, FRACP, discusses the impact that COVID-19 has had and will continue to have on cancer care.

The FDA has issued a complete response letter to Merck stating that regulatory decision for the supplemental biologics license application seeking approval for pembrolizumab for use in patients with high-risk, early-stage triple-negative breast cancer plus chemotherapy as neoadjuvant treatment, then continuing as a single agent as adjuvant treatment following surgery, should be deferred.

The combination of mirvetuximab soravtansine and rucaparib was found to be well tolerated, with encouraging activity reported in heavily pretreated patients with endometrial, ovarian, fallopian tube, or primary peritoneal cancer.

The European Commission has granted conditional marketing authorization for selinexor for use in combination with dexamethasone for the treatment of adult patients with multiple myeloma who have previously received at least 4 therapies and whose disease is refractory to at least 2 proteasome inhibitors, 2 immunomodulatory agents, and an anti-CD38 monoclonal antibody, and have experienced progressive disease on their last therapy.

Japan’s Ministry of Health, Labour and Welfare has approved lisocabtagene maraleucel, a CAR T-cell therapy designed to target CD19, for the treatment of patients with relapsed or refractory large B-cell lymphoma, as well as relapsed/refractory follicular lymphoma.

The use of biosimilars to treat patients may differ across drug classes, according to a new study examining the relationship between biosimilar use and practice setting and patient/physician characteristics.

The European Medicines Agency has validated its type II variation application for nivolumab as an adjuvant treatment for patients with surgically resected, high-risk muscle-invasive urothelial carcinoma.

The rolling submission of a biologics license application to support the approval of ublituximab plus umbralisib as a treatment for patients with chronic lymphocytic leukemia has been completed.

Nikhil C. Munshi, MD, discusses the FDA approval of idecabtagene vicleucel for patients with relapsed/refractory multiple myeloma after 4 or more prior lines of therapy, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 monoclonal antibody.

The COVID-19 pandemic created new patient care challenges in oncology, such as how to reduce risks of virus exposure for patients who may be immunocompromised and switching from in-person visits to telemedicine.

Aditi Shastri, MBBS, discusses risk stratification tools, her treatment algorithm for patients with low-risk MDS, and the role of luspatercept in this population.