Kristi Rosa

The FDA has granted pralsetinib a priority review for the treatment of patients with advanced or metastatic RET-mutant medullary thyroid cancer and RET fusion–positive thyroid cancer.

The FDA has approved pralsetinib for the treatment of patients with metastatic, RET fusion–positive non-small cell lung cancer.

A supplemental biologics license application has been filed with the FDA for axicabtagene ciloleucel for the treatment of relapsed or refractory follicular lymphoma and marginal zone lymphoma following 2 or more previous lines of systemic therapy.

Ruxolitinib continued to elicit a significantly higher overall response rate compared with best available therapy at day 28 in patients with steroid-refractory acute graft-versus-host disease.

Capmatinib continued to elicit a significant, durable responses in patients with metastatic non–small cell lung cancer whose tumors harbor a MET exon14 skipping mutation.

Blinatumomab monotherapy as consolidation therapy prior to allogeneic hematopoietic stem cell transplant resulted a significant improvement in event-free survival and a lower risk of recurrence in children with high-risk B-cell precursor–acute lymphoblastic leukemia.

The orally available ROCK2 selective inhibitor belumosudil continues to elicit clinically meaningful overall response rates in patients with chronic graft-versus-host disease (cGVHD) who have received ≥2 prior lines of systemic therapy

The overall response rates with subcutaneous daratumumab proved to be similar to that of the intravenous formulation of the drug irrespective of body weight.

The FDA has approved oral azacitidine for the continued treatment of adult patients with acute myeloid leukemia who achieved first complete remission (CR) or CR with incomplete blood count recovery following intensive induction chemotherapy who are not able to complete intensive curative therapy.

The FDA has granted a priority review to a new drug application for oral paclitaxel and encequidar for use in patients with metastatic breast cancer.

The FDA has granted a priority review to a new drug application for melphalan flufenamide for use in combination with dexamethasone in adult patients with multiple myeloma whose disease is refractory to at least 1 proteasome inhibitor, 1 immunomodulatory agent, and 1 anti-CD38 monoclonal antibody.

The European Commission has approved belantamab mafodotin-blmf for the treatment of adult patients with multiple myeloma who have received at least 4 previous therapies, whose disease is refractory to at least 1 proteasome inhibitor, 1 immunomodulatory agent, and 1 anti-CD38 monoclonal antibody, and who have progressed on their last therapy.

The FDA has approved the FoundationOne Liquid CDx, a liquid biopsy for all solid tumors with multiple companion diagnostic indications.

The investigational immunotherapeutic ERC1671 in combination with granulocyte-macrophage colony-stimulating factor, cyclophosphamide, and bevacizumab showed promising activity in patients with recurrent glioblastoma.

The combination of the off-the-shelf cancer immune primer Ilixadencel and sunitinib has demonstrated promising survival benefit when used as a frontline treatment for newly diagnosed patients with metastatic renal cell carcinoma.

The novel investigational STAMP inhibitor asciminib significantly improved the major molecular response rate compared with bosutinib at 24 weeks in adult patients with Philadelphia chromosome–positive, chronic-phase chronic myeloid leukemia who received prior treatment with 2 or more TKIs.

The FDA has approved a generic form of pemetrexed for intravenous administration as a single-agent in patients with locally advanced or metastatic nonsquamous non–small cell lung cancer that has not progressed following 4 cycles of first-line platinum-based chemotherapy.

The FDA has granted a priority review designation to new drug application for tepotinib as a treatment for patient with metastatic non–small cell lung cancer whose tumors harbor a MET exon 14 skipping mutation identified via an FDA-approved test.

Enasidenib in combination with best supportive care failed to significantly improve overall survival in patients with relapsed/refractory acute myeloid leukemia whose tumors harbor an IDH2 mutation.

Tesetaxel in combination with a reduced dose of capecitabine led to a significant improvement in progression-free survival versus the approved dose of capecitabine alone, meeting the primary end point of the phase 3 CONTESSA trial.

The Japan Pharmaceuticals and Medical Devices Agency has approved pembrolizumab for the treatment of patients with radically unresectable, advanced, or recurrent esophageal squamous cell carcinoma whose tumors are PD-L1–positive, and at an additional recommended dosage of 400 mg every 6 weeks as an intravenous infusion across all adult indications.

Intravenous rigosertib did not meet the primary end point of significantly improved overall survival versus physician’s choice of therapy plus best supportive care in patients with higher-risk myelodysplastic syndromes.

Spartalizumab in combination with dabrafenib and trametinib failed to meet the primary end point of investigator-assessed progression-free survival in treatment-naïve patients with unresectable or metastatic BRAF V600 mutation–positive cutaneous melanoma.

The FDA has approved daratumumab in combination with carfilzomib and dexamethasone for the treatment of patients with relapsed/refractory multiple myeloma who have received 1 or more prior lines of therapy.

The European Commission has granted a marketing authorization to Aybintio, a bevacizumab biosimilar for the treatment of patients with the same types of cancer for which the reference product is indicated in the European Union.

The FDA has granted a fast track designation to paxalisib for the treatment of patients with glioblastoma.

Treatment with repotrectinib resulted in favorable responses in patients with ROS1- or NTRK-driven tumors, regardless of prior treatment with TKIs, according to interim data from the phase 2 TRIDENT-1 trial.

Pembrolizumab in combination with chemotherapy significantly improved overall survival and progression-free survival in the frontline treatment of patients with locally advanced or metastatic esophageal cancer.

The FDA has placed a clinical hold on the phase 1 P-PSMA-101-001 trial examining the autologous CAR T-cell therapy P-PSMA-101 in patients with metastatic castration-resistant prostate cancer.

The FDA has granted a priority review designation to a supplemental biologics license application for a new 4-week, fixed-dose regimen as treatment in approved indications of non–small cell lung cancer and bladder cancer.