Kristi Rosa

A biologics license application has been submitted to the FDA for idecabtagene vicleucel for the treatment of adult patients with relapsed and refractory multiple myeloma.

The FDA has approved the new VENTANA HER2 Dual ISH DNA Probe Cocktail test for use as a companion diagnostic for trastuzumab and to detect HER2 mutations in patients with breast cancer.

The FDA has granted a breakthrough therapy designation to MK-6482 for the treatment of patients with von Hippel-Lindau disease–associated renal cell carcinoma who have nonmetastatic tumors of less than 3 centimeters, unless immediate surgery is necessitated.

Hutchinson China Meditech Limited announces that The China National Medical Products Administration granted priority review to the new drug application for the MET inhibitor savolitinib for the treatment of patients with non–small cell lung cancer with MET exon 14 skipping mutations.

The FDA has granted a fast track designation to BDTX-189 for use in adult patients with solid tumors harboring an allosteric HER2 mutation or an EGFR or HER2 exon 20 insertion mutation who had progressed on previous treatment and have no acceptable options available.

The phase 2 ZENITH20 trial evaluating poziotinib in previously treated patients with non–small cell lung cancer and HER2 exon 20 insertion mutations met its prespecified primary end point.

The European Medicines Agency has granted access to the PRIME initiative for the Specific Peptide Enhanced Affinity Receptor T-cell therapy ADP-A2M4 for the treatment of patients with synovial sarcoma.

The European Medicines Agency’s Committee for Medicinal Products for Human Use has adopted a positive opinion for ibrutinib in combination with rituximab for use in treatment-naïve patients with chronic lymphocytic leukemia.

Although antibody-drug conjugates have yet to receive regulatory approval in the lung cancer space, several emerging agents are showing early promise in clinical trials.

The European Medicines Agency’s Committee for Medicinal Products for Human Use has adopted a positive opinion for belantamab mafodotin as a monotherapy in the treatment of adult patients with multiple myeloma who have received at least 4 prior therapies and whose disease is refractory to at least 1 proteasome inhibitor, 1 immunomodulatory agent, and aCD38-directed monoclonal antibody.

The mortality rate with COVID-19 appears to be higher in patients with cancer—especially those with lung cancer—compared with the general population, and several factors associated with mortality are beginning to emerge.

The FDA has granted a fast track designation for the PKCβ inhibitor enzastaurin for the treatment of patients with newly diagnosed glioblastoma.

The FDA’s Oncologic Drugs Advisory Committee has scheduled a date to review data supporting the biologics license application for remestemcel-L as a treatment for children with steroid-refractory acute graft versus host disease.

The China National Medical Products Administration has accepted a new drug application for ripretinib as a treatment for adult patients with advanced gastrointestinal stromal tumor who have received previous treatment with 3 or more kinase inhibitors, including imatinib.

The situation with the coronavirus-19 pandemic continues to rapidly evolve, but one thing is clear: this is much more than just the common cold.

The FDA has accepted a supplemental new drug application seeking approval for selinexor for the treatment of patients with multiple myeloma following at least 1 previous line of therapy.

Angela DeMichele, MD, MSCE, shares how to utilize available data with CDK4/6 inhibitors in the neoadjuvant and adjuvant settings to optimize outcomes for patients with hormone receptor–positive breast cancer.

Paolo Ghia, MD, PhD, discusses the final results from the phase 3 ASCEND trial with acalabrutinib monotherapy in patients with relapsed/refractory CLL.

The European Medicines Agency has validated a Marketing Authorization Application for the CD19-directed CAR T-cell therapy lisocabtagene maraleucel for the treatment of adult patients with relapsed/refractory diffuse large B-cell lymphoma, primary mediastinal B-cell lymphoma, and grade 3B follicular lymphoma following at least 2 prior therapies.

Anthracycline-based chemotherapy followed by ado-trastuzumab emtansine plus pertuzumab did not show statistically significant or clinically meaningful improvement in invasive disease-free survival in patients with high-risk HER2-positive early breast cancer, missing the primary end point of the phase 3 KAITLIN trial.

The independent data monitoring committee has recommended that Celsion Corporation consider stopping the global, phase 3 OPTIMA trial examining ThermoDox® in combination with radiofrequency ablation for the treatment of patients with hepatocellular carcinoma.

Results from the phase 3 IMagyn050 trial showed that the addition of atezolizumab to bevacizumab, paclitaxel, and carboplatin did not meet the primary end point of progression-free survival for first-line treatment of women with newly diagnosed, advanced ovarian cancer.

A panel of experts in chronic myeloid leukemia share insight on how to optimally approach treatment based on patient characteristics.

Efbemalenograstim alpha (F-627) has demonstrated strong and lasting benefit when used as a treatment for chemotherapy-induced neutropenia in patients with breast cancer, meeting the primary and secondary end points of a phase 3 study.

The United Kingdom’s National Institute for Health and Care Excellence has recommended brentuximab vedotin (Adcetris) in combination with cyclophosphamide, doxorubicin, and prednisone as a treatment option in treatment-naïve patients with systemic anaplastic large cell lymphoma.

The FDA has granted priority review to a new supplemental biologics license application for pembrolizumab monotherapy as a treatment for adult patients with relapsed/refractory classical Hodgkin lymphoma.

The FDA has issued a complete response letter to Merck and Eisai stating that it will not approve the applications that are seeking the accelerated approval of pembrolizumab in combination with lenvatinib for the frontline treatment of patients with unresectable hepatocellular carcinoma.

Research efforts have revealed a potential weapon to add to the treatment arsenal against COVID-19, a drug that has historically played a crucial role in oncology treatment: the inexpensive, and widely accessible, corticosteroid dexamethasone.

The FDA has approved an oral combination comprised of decitabine and cedazuridine for the treatment of select adult patients with myelodysplastic syndromes.

The FDA has issued a clinical hold on the phase 1 MELANI-01 trial evaluating the CAR T-cell product UCARTCS1A in the treatment of patient with relapsed/refractory multiple myeloma.