Kristi Rosa

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.

The European Medicines Agency’s advisory group, the Committee for Medicinal Products for Human Use, has recommended against the acceptance of the marketing authorization for pexidartinib (Turalio) for the treatment of patients with tenosynovial giant cell tumor.

The Committee for Medicinal Products for Human Use has recommended approval of Aybintio, a bevacizumab (Avastin) biosimilar for the treatment of patients with the same types of cancer for which the reference product is indicated in the European Union.

The European Commission has approved luspatercept-aamt (Reblozyl) as a treatment for patients with transfusion-dependent anemia from very low-, low-, and intermediate-risk myelodysplastic syndromes with ring sideroblasts who had unsatisfactory response or are not candidates for erythropoietin-based therapy, and patients with transfusion-dependent anemia linked with beta thalassemia.

The United Kingdom’s National Institute for Health and Care Excellence has chosen to not recommend abiraterone acetate with prednisone/prednisolone plus androgen deprivation therapy as a treatment for patients with newly diagnosed, high-risk hormone-sensitive metastatic prostate cancer.

The FDA has lifted a partial clinical hold that had been placed on the phase 2 TELLOMAK trial, which is examining the safety and efficacy of lacutamab in patients with advanced T-cell lymphoma.

The FDA has launched a new initiative called Project Patient Voice, which is a website that will serve as a source of publicly available information regarding patient-reported symptoms from cancer trials examining marketed treatments.

The combination of nivolumab and ipilimumab provided similar clinical benefit to that of chemotherapy when given as a frontline treatment for patients with advanced non–small cell lung cancer who had stable and treated brain metastases at baseline.

A supplemental new drug application has been submitted to the FDA for review for the use of ibrutinib in combination with rituximab as a treatment for patients with Waldenström macroglobulinemia.

The China National Medical Products Administration has accepted a supplemental new drug application for tislelizumab in combination with chemotherapy for the frontline treatment of patients with advanced nonsquamous non–small cell lung cancer.

Tucatinib was found to be a potent inhibitor of HER2-mutant signaling in vitro.

The FDA has approved burosumab-twza (Crysvita) injection for the treatment of patients aged 2 and older with tumor-induced osteomalacia, which is described as the development of tumors that cause weakened and softened bones.

The FDA has scheduled an Oncologic Drugs Advisory Committee hearing for July 14, 2020, to discuss data supporting a biologics license application for belantamab mafodotin for the treatment of patients with relapsed/refractory multiple myeloma who have previously received at least 4 prior therapies.

The use of adjuvant immunotherapy in patients with resected stage IIIC melanoma resulted in improved survival benefit, according to real-world data from an early analysis of the National Cancer Database.

The European Medicines Agency has validated and accepted a marketing authorization application for zanubrutinib for the treatment of patients with Waldenström macroglobulinemia who have received at least 1 prior therapy or as frontline treatment for patients who are ineligible for chemoimmunotherapy.

The FDA has granted a fast track designation to fruquintinib for the treatment of patients with metastatic colorectal cancer who have received prior fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy, VEGF-directed therapy, and EGFR-directed therapy.

The United Kingdom’s National Institute for Health and Care Excellence has chosen not to recommend caplacizumab-yhdp (Cablivi) for use with plasma exchange and immunosuppression in the treatment of acute episodes of acquired thrombotic thrombocytopenic purpura in adults and those aged 12 years and over who weigh at least 40 kg.

The United Kingdom’s National Institute for Health and Care Excellence has recommended entrectinib (Rozlytrek) as a treatment option for ROS1-positive advanced non–small cell lung cancer in adults who have not received prior treatment with ROS1 inhibitors.

The FDA has approved lurbinectedin (Zepzelca) for the treatment of adult patients with metastatic small cell lung cancer with disease progression, following platinum-based chemotherapy.

The FDA has approved an expanded indication for Gardasil 9 for the prevention of oropharyngeal and other head and neck cancers caused by human papillomavirus types 16, 18, 31, 33, 45, 52, and 58.