Kristi Rosa

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.

The novel antibody-drug conjugate sacituzumab govitecan-hziy demonstrated significant improvement in survival in patients with triple-negative breast cancer without brain metastases who previously received at least 2 prior therapies for metastatic disease.

The FDA has lifted a partial clinical hold that was placed on the phase 2 clinical trial of camidanlumab tesirine in patients with relapsed/refractory Hodgkin lymphoma.

A new drug application has been submitted to the FDA for pralsetinib (BLU-667) for the treatment of patients with advanced or metastatic RET-mutant medullary thyroid cancer and RET fusion–positive thyroid cancers.

The regimen of liposomal irinotecan plus 5-fluorouracil/leucovorin plus oxaliplatin demonstrated a tolerable safety profile with promising antitumor activity when used as frontline treatment in patients with locally advanced or metastatic pancreatic ductal adenocarcinoma.

The FDA has approved avelumab (Bavencio) for the maintenance treatment of patients with locally advanced or metastatic urothelial carcinoma that has not progressed with first-line platinum-based chemotherapy.

Exelixis, Inc. has launched the phase 3 CONTACT-02 trial examining cabozantinib in combination with atezolizumab in patients with metastatic castration-resistant prostate cancer who have received prior treatment with 1 novel hormonal therapy.

A biologics license application has been submitted to the FDA for omburtamab, previously referred to as burtomab, for the treatment of pediatric patients with central nervous system/leptomeningeal metastases from neuroblastoma.

A new drug application has been submitted to the FDA seeking an accelerated approval for melphalan flufenamide in combination with dexamethasone in the treatment of adult patients with triple-refractory multiple myeloma.

The antibody-drug conjugate tisotumab vedotin induced clinically meaningful and durable responses in patients who have relapsed or progressed on or after previous treatment for recurrent or metastatic cervical cancer.

The FDA has approved pembrolizumab (Keytruda) for the first-line treatment of patients with unresectable or metastatic microsatellite instability–high or mismatch repair deficient colorectal cancer.

The Japanese Ministry of Health, Labor, and Welfare has approved capmatinib for patients with MET exon 14 skipping mutation–positive advanced and/or recurrent unresectable non–small cell lung cancer.

The FDA has approved a fixed-dose combination of pertuzumab (Perjeta) and trastuzumab (Herceptin) with hyaluronidase, administered via subcutaneous injection in combination with intravenous chemotherapy, for the treatment of early and metastatic HER2-positive breast cancer.