Kristi Rosa

The FDA has granted priority review to the supplemental biologics license application for luspatercept-aamt for the treatment of anemia in adults with non–transfusion dependent β-thalassemia.

The FDA has approved rituximab plus chemotherapy for pediatric patients with previously untreated, advanced stage, CD20-positive diffuse large B-cell lymphoma, Burkitt lymphoma, Burkitt-like lymphoma, or mature B-cell acute leukemia.

Secura Bio decided to withdraw the approval of the new drug application for panobinostat for use in combination with bortezomib and dexamethasone to treat select patients with multiple myeloma.

The FDA’s Centers for Devices and Radiological Health has granted a breakthrough device designation to ZetaMet technology for use in the treatment of metastatic bone cancers and osteologic interventions.

The FDA has approved daratumumab and hyaluronidase-fihj plus carfilzomib and dexamethasone for the treatment of adult patients with relapsed or refractory multiple myeloma who have received 1 to 3 prior lines of therapy.

The FDA has issued a complete response letter to the new drug application seeking the approval of plinabulin in combination with granulocyte colony-stimulating factor for the prevention of chemotherapy-induced neutropenia.

The FDA has extended the review period for the new drug application for pacritinib as a treatment for adult patients with intermediate- or high-risk primary or secondary (post-polycythemia vera or post-essential thrombocythemia) myelofibrosis and severe thrombocytopenia with a baseline platelet count of 50 x 109/L.

The FDA has granted a fast track designation to arfolitixorin as a potential therapeutic option for patients with metastatic colorectal cancer.

The FDA has approved maribavir for the treatment of adult and pediatric patients aged 12 years and older weighing at least 35 kg who have post-transplant cytomegalovirus infection that does not respond to available antiviral treatment.

The targeted small molecule inhibitor of the E26 transformation-specific family of oncoproteins, ONCT-216, produced notable response and disease control rates when delivered at the recommended phase 2 dose to heavily pretreated patients with Ewing sarcoma.

The European Commission granted marketing authorization for sacituzumab govitecan-hziy for use as a monotherapy in the treatment of adult patients with unresectable or metastatic triple-negative breast cancer who have previously received 2 or more systemic therapies, at least 1 of them for advanced disease.

The FDA has approved sirolimus albumin-bound particles for injectable suspension for the treatment of adult patients with locally advanced unresectable or metastatic malignant perivascular epithelioid cell tumor.

The addition of sintilimab to a bevacizumab biosimilar and pemetrexed/cisplatin resulted in a statistically significant and clinically meaningful improvement in progression-free survival vs chemotherapy alone in patients with EGFR-mutated, nonsquamous non–small cell lung cancer who progressed after an EGFR TKI.

The European Commission has granted a conditional marketing authorization to pralsetinib for use as a single agent in adult patient with RET fusion–positive advanced non–small cell lung cancer who did not previously receive a RET inhibitor.

The addition of quizartinib to chemotherapy resulted in a statistically significant and clinically meaningful improvement in overall survival vs standard chemotherapy alone in patients with newly diagnosed, FLT3-ITD–positive acute myeloid leukemia.

The FDA has approved pembrolizumab for the adjuvant treatment of patients with renal cell carcinoma who are at intermediate-high or high risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesions.

Sacituzumab govitecan-hziy significantly improved overall response rate in Chinese patients with metastatic triple-negative breast cancer.

The combination of the PD-1/VEGF bispecific antibody AK112 and the PARP inhibitor olaparib is under investigation as a potential treatment option for patients with BRCA1/2 germline wild-type, platinum-sensitive, recurrent ovarian cancer as part of a phase 1b/2 trial.

The investigative agent SL-172154 was found to be well tolerated, with no dose-limiting toxicities observed, in patients with platinum-resistant ovarian cancer, according to findings from a phase 1 dose-escalation trial presented during the 2021 SITC Annual Meeting.

The FDA granted an orphan drug designation to toripalimab for the treatment of patients with esophageal cancer.

Tidutamab was found to be well tolerated with a best overall response of stable disease in patients with advanced, well-differentiated neuroendocrine tumors of pancreatic, gastrointestinal, lung and undetermined origin.

ICT01, a humanized anti-BTN3A monoclonal antibody that selectively activates γ9δ2 T cells, has demonstrated early signs of biological activity when given as a single agent or in combination with pembrolizumab in patients with advanced solid tumors.

The FDA has approved ropeginterferon alfa-2b-njft for use as a treatment in patients with polycythemia vera.

The European Medicines Agency’s Committee for Medicinal Products for Human Use has adopted a positive opinion recommending the conditional marketing authorization of sotorasib for the treatment of adult patients with advanced non–small cell lung cancer whose tumors harbor a KRAS G12C mutation and who have progressed after at least 1 prior line of systemic therapy.

Gamida Cell Ltd. has completed a Type B Pre-Biologics License Application meeting with the FDA to discuss the investigational advanced cell therapy omidubicel as a potential therapeutic option for patients with blood cancers who require stem cell transplant.

The FDA has granted an orphan drug designation to LYT-200, a fully human IgG4 monoclonal antibody targeting galectin-9, for use as a potential therapeutic option for patients with pancreatic cancer.

The combination of nivolumab and low-dose ipilimumab resulted in a deep and durable clinical benefit when used in the first-line treatment of patients with microsatellite instability–high and mismatch repair deficient metastatic colorectal cancer.

The FDA has granted an orphan drug designation to the HER2-targeted natural killer cell engager therapy, DF1001, as a potential therapeutic option for patients with esophageal cancer.

The FDA has greenlit an investigation new drug application to expand the ongoing phase 1/2 ABILITY trial, which is evaluating the beta-only IL-2 superagonist MDNA11 in patients with solid tumors, to clinical trial sites in the United States.

The FDA granted a fast track designation to the selective AXL inhibitor bemcentinib in combination with a PD-1/PD-L1 agent in the treatment of patients with STK11-altered advanced or metastatic non–small cell lung cancer without actionable mutations.