News

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Atezolizumab (is being voluntarily withdrawn from the US market by Roche for its indication as a treatment for patients with prior-platinum treated metastatic urothelial carcinoma.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

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.

During a Targeted Oncology virtual event, Ajay K. Nooka, MD, MPH discussed the case of a patient with stage II multiple myeloma.

Markus Moehler, MD, PhD, discusses the survival outcomes of nivolumab in combination with chemotherapy in patients with advanced gastric cancer.

Pembrolizumab has been withdrawn from the United States market as a treatment option for patients with metastatic small cell lung cancer with disease progression on or after platinum-based chemotherapy and at least one other prior line of therapy.

Updated data show a continued survival benefit for patients with metastatic renal cell carcinoma as the group reached the median overall survival endpoint for the phase II MERECA study.

Treatment with lanreotide autogel in patients with pancreatic neuroendocrine tumors, and midgut neuroendocrine tumors did not cause deterioration in quality-of-life, according to new data from the Phase II CLARINET FORTE study.

Here is a look back at the FDA happenings from the month of February 2021.

The FDA has issued a complete response letter to Athenex, Inc, regarding the New Drug Application for oral paclitaxel in combination with encequidar for the treatment of metastatic breast cancer. The FDA stated that the application review process has been completed, but the NDA is not ready for approval due to safety and efficacy concerns.

The FDA has issued an emergency use authorization for a third vaccine, the Janssen COVID-19 Vaccine, for the prevention of COVID-19 caused by SARS-CoV-2.

The FDA has granted approval to melphalan flufenamide in combination with dexamethasone for the treatment of adult patients with relapsed or refractory multiple myeloma, who have received at least four prior lines of therapy and whose disease is refractory to at least one proteasome inhibitor, one immunomodulatory agent, and one CD38-directed monoclonal antibody.

The first patient has been dosed in the phase 1/2 clinical trial of an oral CDK9 inhibitor targeting MYC-amplified solid tumors known as KB-0742.

The rising prevalence of thyroid cancer and thyroid nodules, especially for differentiated thyroid cancer, has brought into question the management of disease as it is known today.