News

At a panel at the ACCC 47th Annual Meeting and Cancer Center Business Summit, several oncology professionals discussed the many changes to cancer care that COVID-19 has accelerated and what challenges still lie ahead.

The FDA has extended the review period for the New Drug Application for belumosudil, which is being considered as a potential treatment option for patients with chronic graft-versus-host disease.

The FDA has announced a meeting of the Oncologic Drugs Advisory Committee to review 6 accelerated approvals for immunotherapy agents where the clinical benefit was not verified in confirmatory trials. The ODAC meeting will be taking place April 27 through 29.

Nemvaleukin alfa, an interleukin-2 variant immunotherapy for the treatment of mucosal melanoma, has been granted orphan drug designation by the FDA,

In an interview with Targeted Oncology, Joyce O’Shaughnessy, MD, chair of Breast Cancer Research and chair of Breast Cancer Prevention Research at Baylor-Sammons Cancer Center of Texas Oncology, discussed the CONTESSA stusy of tesetaxel with a reduced dose of capecitabine versus capecitabine alone in patients with HR-positive, HER2-negative breast cancer.

The FDA granted orphan drug designation to the CDK2/4/6 inhibitor, NUV-422, for the treatment of patients with malignant gliomas.

The FDA granted Orphan Drug Designation to the novel GPER agonist, LNS8801, for the treatment of patients with metastatic uveal melanoma.

The first therapy for adults with relapsed or refractory advanced renal cell carcinoma who have received two or more prior systemic therapies has been granted approval by the FDA.

In an interview with Targeted Oncology, Laura Goff, MD, discussed the treatment of hepatocellular carcinoma in the frontline and beyond.

The FDA granted Breakthrough Device Designation for RaDaR assay, a personalized liquid biopsy assay that tracks a set of up to 48 tumor-specific variants in patients with exceptional sensitivity.

The phase 3 GENUINE study demonstrated a response benefit with the addition of the anti-CD20 monoclonal antibody ublituximab to ibrutinib for patients with relapsed or refractory high-risk chronic lymphocytic leukemia.

Results from the phase CANOPY-2 clinical trial of canakinumab in combination with docetaxel as treatment of advanced or metastatic non–small cell lung cancer did not yield a favorable survival outcome.

Richard Finn, MD, discusses the interim results of the REFINE Study, which tests the real-world dosing of regorafenib in patients with unrespectable hepatocellular carcinoma.

The FDA has granted approval to the VENTANA ALK CDx Assay as a companion diagnostic to identify patients with ALK-positive non–small cell lung cancer who may be eligible for treatment with the recently approved ALK inhibitor lorlatinib.

In an interview with Targeted Oncology, Margaret von Mehren, MD, reviews the recent advancements in the GIST treatment landscape. She also explains what’s needed to move the needle further in the future.

In an interview with Targeted Oncology, Julia K. Rotow, MD, a medical oncologist at the Dana-Farber Cancer institute, discuses the results of the study of gefitinib in combination with osimertinib as frontline treatment of patients with EGFR-mutated NSCLC.

Atezolizumab (is being voluntarily withdrawn from the US market by Roche for its indication as a treatment for patients with prior-platinum treated metastatic urothelial carcinoma.

The FDA has granted an Orphan Drug Designation to Padeliporfin Immune Photo Activated Cancer Therapy for the treatment of adult patients with upper tract urothelial cancer.

The FDA has granted an accelerated approval to axicabtagene ciloleucel for the treatment of adult patients with relapsed or refractory follicular lymphoma who have received 2 or more prior lines of systemic therapy.

In an interview with Targeted Oncology, Markus Moehler, MD, PhD, reviewed the potentially practice-changing data from the phase 3 CheckMate 649 clinical trial.

The novel combined immunotherapy CRX100 has been dosed in the first patient with refractory solid tumors in a phase 1, open-label, dose-escalation study.

As part of the virtual 17th Annual Meeting of the International School of Gastrointestinal Oncology, a debate ensued around whether liver-directed or systemic therapy is best for the treatment of patients with HCC.

A rolling submission of the Biologics License Application was initiated for toripalimab for the treatment of patients with recurrent or metastatic nasopharyngeal carcinoma.

The FDA has accepted a New Drug Application for pafolacianine sodium injection and granted it Priority Review as a potential adjunct for identifying ovarian cancer during surgery.

The FDA has expanded the approval for lorlatinib to include an indication for the first-line treatment of patients with ALK-positive non–small cell lung cancer.

Blinatumomab consolidation demonstrated significantly prolonged event-free survival in pediatric patients with high-risk first-relapse B-cell precursor acute lymphoblastic leukemia when compared with chemotherapy before allogeneic hematopoietic stem cell transplantation.

Full results from the phase 2 KarMMa trial decabtagene vicleucel show the promise of idecabtagene vicleucel in relapsed and refractory multiple myeloma.

The first patient with acute myeloid leukemia in a phase 2 trial of the MultiTAA-specific T cell, MT-401 followed stem-cell transplant has been dosed with the agent, according to a press release by Marker Therapeutics, Inc.

Alex F. Herrera, MD, discusses the use of the antibody-drug conjugate, camidanlumab tesirine for the treatment of relapsed or refractory Hodgkin lymphoma.

In an interview with Targeted Oncology, Hang Quach, MD, discussed the phase 2 Australasian Leukaemia and Lymphoma Group MM 018/ Asian Myeloma Network 002 study and how it can impact the treatment of R/R/ multiple myeloma in the future.