News

The FDA has granted approval to axicabtagene ciloleucel for the treatment of adult patients with large B-cell lymphoma that is refractory to first-line chemoimmunotherapy or relapses within 12 months of first-line chemoimmunotherapy, according to an announcement from the FDA.

A survival benefit has been shown in a phase 2 study using intermittent relacorilant and nab-paclitaxel for the treatment of patients with recurrent, platinum-resistant ovarian cancer.

For the second time, an application for approval has been submitted for the FDA for I-omburtamab for the treatment of pediatric patients with central nervous system or leptomeningeal metastasis from neuroblastoma.

Use of trilaciclib prior to chemotherapy demonstrated a substantial burden of myelosuppressive hematologic adverse events within the patients with extensive-stage small-cell lung cancer.

Here's a look back at all the FDA happenings from March 2022.

Selpercatinib is a promising treatment option for Chinese patients with RET-altered thyroid cancer, according to LIBRETTO-321 results.

The phase 3 ATHENA-MONO trial meet it primary end point of improvement in progression-free survival with rucaparib in patients with newly-diagnosed, advanced ovarian cancer.

Improving gender and racial/ethnic minority inclusion in clinical trials may involve setting an oncology-wide standard.

Jennifer Brown, MD, PhD discusses the purpose of the SEQUOIA trial in patients with treatment-naïve chronic lymphocytic leukemia.

The FDA has accepted for priority review a new drug application for futibatinib seeking approval for the treatment of patients with previously treated locally advanced or metastatic cholangiocarcinoma who harbor FGFR2 gene rearrangement, including gene fusions.

Orphan drug designation has been granted to Veyonda as a form of treatment in patients with soft tissue sarcoma.

Tumor treating fields in combination with paclitaxel in patients with platinum-resistant ovarian cancer, has been recommended by an independent data monitoring committee to proceed to the final analysis based on data from the phase 3 INNOVATE-3 trial.

Vivek Subbiah, MD, discusses what sets medullary thyroid cancer apart from other thyroid histologies.

The FDA recently approved Lu 177 vipivotide tetraxetan for use in patients with metastatic castration-resistant prostate cancer.

In an interview with Targeted Oncology, Ravi Salgia, MD, PhD, discussed the research leading to the first-in-human study of LB-100 combined with chemotherapy or immunotherapy to address transformation to small cell lung cancer.

Charles Geyer, MD, discusses olaparib for the treatment of patients with BRCA-positive, HER2-negative high-risk early breast cancer as evaluated in the OlympiA study.

An application for approval has been submitted to the FDA for mirvetuximab soravtansine to treat patients with folate receptor alpha-high platinum-resistant ovarian cancer.

Pembrolizumab and MRx0518 has shown clinical benefit in patients with renal cell carcinoma that have progressed on a prior immune checkpoint inhibitor.

Venetoclax consolidation after 12-cycles of treatment increases the duration of known toxicities and does not prevent the loss of minimal residual disease response and subsequent risk of disease relapse in patients with previously untreated chronic lymphocytic leukemia, a study shows.

The phase 3 CALLA study did not achieve its key end point of progression-free survival improvement with the addition of durvalumab to chemoradiotherapy in patients with locally advanced cervical cancer.

Nicholas J. Vogelzang, MD, discusses some of the approvals and different regimens seen in today’s renal cell carcinoma treatment landscape.

Treatment options have expanded widely for patients with multiple myeloma over the past several years, resulting in significantly improved outcomes for these patients.

Chimeric antigen receptor expansion by day 10 could be an early biomarker to predict response and survival in patients with B-cell lymphoma.

During a debate at the Gastrointestinal Cancers Symposium, Florian Lordick, MD, argued that knowledge of PD-L1 expression level was needed before starting immune checkpoint inhibitor therapy. He was challenged by Aaron James Scott, MD, who argued that knowledge of PD-L1 is not necessary before initiating immune checkpoint inhibitor therapy.

Results from the phase 1b EQUATE study were favorable enough to initiate a phase 3 study, which will test itolizumab for the frontline treatment of acute graft-versus-host disease..

The FDA is no longer conducting a speedy review of the supplemental biologics license application for luspatercept-aamt as treatment for anemia in adults with non-transfusion-dependent beta thalassemia.

In an interview with Targeted Oncology, C.K. Wang, MD, discussed the importance of real-world data in oncology, the mission of COTA, and research the company has been a part of.

TST001 has shown to be safe in ongoing trials alone or in combination with chemotherapy and displayed encouraging anti-tumor activity signals in gastric cancer and other solid tumor patients expressing CLDN18.2.

The FDA discouraged marketing authorization for zandelisib based data from the phase 2 TIDAL study which examined the PI3K inhibitor in subjects with relapsed/refractory follicular lymphoma or marginal zone lymphoma.