Kristi Rosa

The FDA has granted a priority review to the supplemental new drug application for ivosidenib tablets as a treatment option for patients with previously treated, IDH1-mutant cholangiocarcinoma.

The addition of motixafortide to granulocyte colony stimulating factor resulted in a 4.9-fold increase in achieving target stem-cell mobilization for autologous bone marrow transplantation in up to 2 apheresis sessions vs G-CSF alone in patients with multiple myeloma, meeting the primary end point of the phase 3 GENESIS trial.

RAD51C and RAD51D mutations and high-level BRCA1 promotor methylation are predictive of response to rucaparib in patients with recurrent ovarian cancer, while genomic scars linked with homologous recombination deficiency is predictive of response only in those with platinum-sensitive disease.

The European Commission has approved enzalutamide for the treatment of adult patients with metastatic hormone-sensitive prostate cancer.

The rolling submission of a new drug application to the FDA for surufatinib for the treatment of patients with pancreatic and non-pancreatic neuroendocrine tumors has been completed.

Whole-genome sequencing has the potential to accurately differentiate between stable and progressive precursor conditions to multiple myeloma in low disease burden clinical states and the use of this technology in the clinic may result in a significant shift in the management of these patients.

A marketing authorization application has been submitted to the European Medicines Agency for the approval of the CAR T-cell therapy ciltacabtagene autoleucel in the treatment of patients with relapsed and/or refractory multiple myeloma.

The novel oral TKI masitinib in combination with docetaxel and prednisone resulted in improved progression-free survival compared with docetaxel plus prednisone in patients with metastatic castration-resistant prostate cancer, meeting the predefined primary end point of the phase 2b/3 AB12003 trial.

The FDA has granted a priority review designation to a supplemental biologics license application for nivolumab for use as an adjuvant treatment in patients with surgically resected, high-risk, muscle-invasive urothelial carcinoma.

Centrally stratified risk-adapted clinical trials in patients with newly diagnosed multiple myeloma were shown to be feasible, addressing an unmet need and providing the opportunity for rapid clinical development of novel therapies.

Tocilizumab may represent a potential treatment option with double action against cytokine storm due to COVID-19 in a subset of patients with active multiple myeloma and severe infection with the virus.

Regulatory submissions for the combination of apalutamide plus abiraterone acetate and prednisone in the treatment of chemotherapy-naïve patients with metastatic castration-resistant prostate cancer will not be pursued.

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.