Gina Columbus

Treatment with brigatinib demonstrated a 57% reduction in the risk of disease progression or death compared with crizotinib in patients with advanced ALK-positive non–small cell lung cancer who had not received a prior ALK inhibitor.

The combination of nivolumab and ipilimumab did not show a statistically significant improvement in recurrence-free survival compared with single-agent nivolumab as an adjuvant treatment for patients who have had complete surgical removal of stage IIIB/C/D or stage IV melanoma and whose tumors expressed PD-L1

The European Commission has approved pembrolizumab as a monotherapy or in combination with platinum and 5-FU chemotherapy for the frontline treatment of patients with metastatic or unresectable recurrent head and neck squamous cell carcinoma and PD-L1 expression (composite positive score ≥1) on their tumors.

The European Commission has approved the triplet regimen of daratumumab with lenalidomide and dexamethasone for the treatment of adult patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant.

Treatment with relugolix achieved a high rate of sustained testosterone suppression to castrate levels in patients with androgen-sensitive advanced prostate cancer, meeting the primary endpoint of the phase III HERO trial.

The FDA has accepted a biologics license application for the proposed bevacizumab biosimilar SB8.

The combination of vemurafenib and cobimetinib led to a 5-year overall survival rate of nearly 40% in patients with BRAF V600E–mutant metastatic melanoma who had not received prior therapy with a BRAF inhibitor.

The European Medicines Agency’s Committee for Medicinal Products for Human Use has issued a positive opinion for a Marketing Authorization Application of fostamatinib disodium hexahydrate for the treatment of adult patients with chronic immune thrombocytopenia who are refractory to other treatments.

The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended the combination of lenalidomide and rituximab for the treatment of adult patients with grade 1 to 3a previously treated follicular lymphoma.

The FDA has granted an accelerated approval to zanubrutinib capsules for the treatment of adult patients with mantle cell lymphoma who have received ≥1 prior therapy.

Secondary cytoreduction followed by chemotherapy was not found to improve overall survival compared with chemotherapy alone in patients with platinum-sensitive recurrent ovarian cancer.

Treatment with the selective ROCK2 inhibitor KD025 led to statistically significant overall response rates in patients with chronic graft-versus-host disease who have received ≥2 prior lines of systemic therapy.

Varlitinib combined with capecitabine did not improve progression-free survival nor overall response rate compared with capecitabine/placebo as a second-line treatment in patients with biliary tract cancer.

The FDA has granted a priority review designation to a supplemental biologics license application for the combination of nivolumab and ipilimumab for the treatment of patients with advanced hepatocellular carcinoma who received prior therapy with sorafenib.

The FDA has approved luspatercept-aamt (Reblozyl) for the treatment of anemia in adult patients with beta thalassemia who require regular red blood cell transfusions.

A supplemental new drug application has been submitted to the FDA for ibrutinib (Imbruvica) for use in combination with rituximab (Rituxan) for the first-line treatment of patients ≤70 years old with chronic lymphocytic leukemia or small lymphocytic lymphoma.

Ixazomib significantly improved progression-free survival as a first-line maintenance therapy compared with placebo in adult patients with multiple myeloma who have not undergone stem cell transplantation, meeting the primary endpoint of the phase III TOURMALINE-MM4 study.

The combination of INO-5401 and INO-9012 with cemiplimab, plus chemoradiation, demonstrated promising 6-month progression-free survival rates in patients with newly diagnosed glioblastoma multiforme that is O6-methylguanine-DNA methyltransferase methylated or unmethylated.

The FDA has approved the pegfilgrastim biosimilar LA-EP2006 (pegfilgrastim-bmez; Ziextenzo) as a treatment to decrease the incidence of infection, exhibited from febrile neutropenia, in patients with nonmyeloid malignancies receiving myelosuppressive anti-cancer therapy that is associated with a clinically significant incidence of febrile neutropenia.

The investigational agent pegvorhyaluronidase alfa in combination with gemcitabine and nab-paclitaxel did not show an improvement in overall survival compared with gemcitabine and nab-paclitaxel alone in patients with metastatic pancreatic cancer, missing the primary endpoint of the phase III HALO-109-301 trial.

Gilteritinib demonstrated a higher remission rate and a statistically significant improvement in overall survival compared with salvage chemotherapy in patients with relapsed/refractory acute myeloid leukemia who harbor a FLT3 mutation.

The FDA has granted a Regenerative Medicine Advanced Therapy designation to the investigational anti-BCMA CAR T-cell therapy CT053 for the treatment of patients with relapsed/refractory multiple myeloma.

The investigational KRAS G12C inhibitor MRTX849 demonstrated clinical activity in patients with non–small cell lung cancer and colorectal cancer.

The addition of durvalumab (Imfinzi) to platinum-based chemotherapy demonstrated a statistically significant and clinically meaningful improvement in progression-free survival compared with chemotherapy alone in patients with previously untreated metastatic non–small cell lung cancer.

Treatment with iodine-131 apamistamab led to a high bone marrow transplant rate compared with salvage chemotherapy in elderly patients with relapsed/refractory acute myeloid leukemia.

The FDA has informed Blueprint Medicines that it intends to split the proposed indications for its agent avapritinib into two separate new drug applications for patients with gastrointestinal stromal tumor (GIST): one for patients with PDGFRA exon 18–mutant disease regardless of prior therapy, and one for fourth-line GIST.

MCLA-128, an investigational bispecific HER2/HER3 antibody, demonstrated radiological and clinical responses in patients with metastatic pancreatic ductal adenocarcinoma and metastatic non–small cell lung cancer who have NRG1 fusions.

An updated biologics license application has been submitted to the FDA for eflapegrastim for the management of chemotherapy-induced neutropenia.

The European Commission has approved gilteritinib as a single agent for the treatment of relapsed/refractory patients with FLT3-mutant acute myeloid leukemia.

The combination of ublituximab and ibrutinib improved progression-free survival, as determined by an Independent Review Committee, compared with ibrutinib alone in patients with relapsed/refractory high-risk chronic lymphocytic leukemia.