Kristi Rosa

The FDA has approved the Oncomine Dx Target Test as a companion diagnostic to identify patients with RET fusion–positive non¬–small lung cancer who are candidates to receive the recently approved targeted therapy pralsetinib.

The European Commission has approved an expanded indication of ibrutinib for use in combination with rituximab in treatment-naïve adult patients with chronic lymphocytic leukemia.

The China National Medical Products Administration has approved niraparib for use as a first-line maintenance treatment in adult patients with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer who achieve a complete or partial response to first-line platinum-based chemotherapy.

The FDA has granted a breakthrough therapy designation to plinabulin for chemotherapy-induced neutropenia.

A supplemental biologics license application has been submitted to the FDA for daratumumab plus hyaluronidase-fihj for the treatment of patients with amyloid light chain amyloidosis.

The first-in-class radioiodinated phospholipid drug conjugate CLR 131 elicited a clinically meaningful overall response rate of 40% in patients with triple-class refractory multiple myeloma who received a total administered dose of 60 mCi or greater.

The FDA has approved copper Cu 64 dotatate injection for the localization of somatostatin receptor–positive neuroendocrine tumors.

The FDA has issued an alert that the phase 3 IMpassion131 trial failed to show the effectiveness of atezolizumab plus paclitaxel in treatment-naïve patients with inoperable locally advanced or metastatic triple-negative breast cancer.

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.