News

Patients with relapsed or refractory high-risk chronic lymphocytic leukemia achieved a statistically higher rate of overall response when the glycoengineered, type I anti-CD20 monoclonal antibody ublituximab was added to the Bruton’s tyrosine kinase inhibitor ibrutinib, according to results from the phase 3 GENUINE study.

Undergoing colorectal screening can be a challenge for people who don’t have insurance or are underinsured, so the Colon Cancer Prevention Project was created in Kentucky to help establish programs to improve access to screening, including the Kentucky Colon Cancer Screening and Prevention Program.

A phase 3 trial for cemiplimab monotherapy in comparison with chemotherapy in patients with recurrent or metastatic cervical cancer who previously received chemotherapy treatment is being stopped early due to a unanimous recommendation by the Independent Data Monitoring Committee due to positive overall survival results.

The FDA has issued a complete response letter to PharmaEssentia Corporation for the company’s biologics license application for ropeginterferon alfa-2b-njft as a potential treatment for patients with polycythemia vera.

In an interview with Ecaterina Ileana Dumbrava, MD, discussed the ongoing study of BDC-1001 alone and in combination with an immune checkpoint inhibitor for the treatment of HER2-positive breast cancer and other solid tumors.

The FDA has granted a fast-track designation to the tyrosine kinase inhibitor, poziotinib for the treatment of previously treated patients with non-small cell lung cancer whose tumors harbor a HER2 exon 20 mutation.

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.