Kristi Rosa

Health Canada has approved daratumumab injection, a subcutaneous formulation of daratumumab, for use in combination with bortezomib, cyclophosphamide, and dexamethasone in the treatment of patients with newly diagnosed light chain amyloidosis.

A biologics license application has been submitted to the FDA seeking the accelerated approval of balstilimab for use in the treatment of patients with recurrent or metastatic cervical cancer with disease progression on, or following, chemotherapy.

Selinexor resulted in lower rates and slower worsening of pain in patients with advanced unresectable dedifferentiated liposarcoma vs placebo, and may represent a novel option to provide convenience, improved adherence, and reduced caregiver burden vs existing parenteral therapies.

Darovasertib, both as a single agent and in combination with binimetinib, has demonstrated promising early activity in patients with metastatic uveal melanoma, according to preliminary data from an ongoing phase 1/2 trial.

The European Commission has approved isatuximab for use in combination with carfilzomib and dexamethasone in the treatment of patients with relapsed multiple myeloma who have received at least 1 previous therapy.

The FDA has granted priority review to 2 supplemental biologics license applications for enfortumab vedotin-ejfv for the treatment of select patients with locally advanced or metastatic urothelial cancer.

The FDA has approved nivolumab to be combined with select types of chemotherapy for the frontline treatment of patients with advanced or metastatic gastric cancer, gastroesophageal junction cancer, and esophageal adenocarcinoma.

The European Commission has approved the combination of nivolumab and cabozantinib as a frontline treatment in patients with advanced renal cell carcinoma.

The FDA has granted a rare pediatric disease designation to the p-STAT3 inhibitor WP1066 for the treatment of patients with ependymoma, a rare type of tumor that can develop in the brain or the spinal cord.

The China National Medical Products Administration has approved osimertinib for use as an adjuvant treatment in patients with early-stage non–small cell lung cancer with EGFR exon 19 deletions or exon 21 mutations, following tumor resection with curative intent, with or without adjuvant chemotherapy as recommended by the patient’s physician.

The FDA has granted an accelerated approval to sacituzumab govitecan for the treatment of patients with locally advanced or metastatic urothelial cancer who previously received a platinum-containing chemotherapy and either a PD-1 or PD-L1 inhibitor.

The FDA has authorized the marketing of the first device that utilizes artificial intelligence based on machine learning to help clinicians detect lesions like polyps or suspected tumors in the colon in real time during a colonoscopy.

The combination of tislelizumab and sitravatinib demonstrated early antitumor activity and a manageable safety profile in patients with recurrent platinum-resistant epithelial ovarian cancer and were naïve to PD-1/PD-L1 inhibition.

Zenocutuzumab has been shown to block the growth and cause the death of NRG1 fusion–positive cell lines, and to induce tumor shrinkage and durable tumor regression in multiple cancers when used in NRG1 fusion–positive patient-derived xenografts.

Tebentafusp (IMCgp100) resulted in a highly significant and clinically meaningful improvement in overall survival when given as a frontline treatment in patients with metastatic uveal melanoma.

The FDA has granted a priority review to the biologics license application for tisotumab vedotin as a potential treatment for patients with recurrent or metastatic cervical cancer with progressive disease on, or following, chemotherapy.

Daratumumab appears to be safe when used as consolidation therapy in patients with multiple myeloma, even soon after autologous stem cell transplant, and the agent has also demonstrated early efficacy in the setting of very good responders.

Pirtobrutinib showcased encouraging efficacy with an acceptable safety profile in patients with chronic lymphocytic leukemia or small lymphocytic leukemia, mantle cell lymphoma, and Waldenström macroglobulinemia who previously received a BTK inhibitor.

The FDA has granted a fast track designation to the soluble LAG-3 protein eftilagimod alpha for use in the frontline treatment of patients with recurrent or metastatic head and neck squamous cell carcinoma.

Single-agent pembrolizumab resulted in a significant improvement in disease-free survival when used as an adjuvant treatment in patients with renal cell carcinoma following nephrectomy or nephrectomy and resection of metastatic lesions, meeting the primary end point of the phase 3 KEYNOTE-564 trial.

The combination of nivolumab and ipilimumab and nivolumab plus chemotherapy resulted in a statistically significant overall survival benefit compared with chemotherapy alone in patients with unresectable advanced or metastatic esophageal squamous cell carcinoma.

The FDA has recommended the early termination of a phase 2 trial examining the cell-based immunotherapy ERC1671 in combination with granulocyte-macrophage colony-stimulating factor, cyclophosphamide, and bevacizumab in patients with glioblastoma.

The FDA has granted a regular approval to sacituzumab govitecan for the treatment of patients with unresectable locally advanced or metastatic triple-negative breast cancer who have previously received 2 or more systemic therapies, at least 1 of them for metastatic disease.

The FDA has approved a new biweekly dosing regimen of 500 mg/m2 as a 120-minute intravenous infusion for cetuximab (Erbitux) for patients with KRAS wild-type, EGFR-expressing colorectal cancer or squamous cell carcinoma of the head and neck.

The RET inhibitor TPX-0046 demonstrated encouraging preliminary activity, which included objective responses, and an acceptable toxicity profile when used in patients with RET-driven advanced solid tumors.

The rolling submission of a biologics license application to support the approval of the investigational BCMA-directed CAR T-cell therapy ciltacabtagene autoleucel for the treatment of patients with relapsed/refractory multiple myeloma has been completed.

The multitumor-associated antigen-specific T-cell product MT-401 is under investigation as a potential treatment option for patients with acute myeloid leukemia following allogeneic stem cell transplant in both the adjuvant and active disease settings.

The HER3-directed antibody-drug conjugate patritumab deruxtecan is under exploration in the treatment of patients with EGFR-mutated, metastatic or locally advanced non–small cell lung cancer who had previously received a TKI and platinum-based chemotherapy.

The European Medicines Agency’s Committee for Medicinal Products for Human Use has adopted a positive opinion recommending the approval of single-agent duvelisib for the treatment of adult patients with relapsed or refractory chronic lymphocytic leukemia following at least 2 prior therapies, and follicular lymphoma that is refractory to at least 2 prior systemic treatments.

The FDA has granted a breakthrough therapy designation to the FGFR inhibitor futibatinib for the treatment of patients with previously treated, locally advanced or metastatic cholangiocarcinoma that harbors FGFR2 gene rearrangements, including fusions.