A combination of ONCOS-102 plus standard chemotherapy continues to extend the time without disease progression and appears to induce immune system activity in people with malignant pleural mesothelioma unable to undergo surgery, updated results from a Phase 2 clinical trial show. Developed by Targovax, ONCOS-102 is a genetically modified adenovirus designed to infect cancer cells…
The U.S. Food and Drug Administration (FDA) has granted conditional approval to Rubraca (rucaparib) for treating patients with metastatic castration-resistant prostate cancer (mCRPC) and BRCA mutations who have previously received an androgen receptor inhibitor and taxane-based chemotherapy. The agency’s decision was made under an accelerated approval process after previously granting the therapy breakthrough therapy designation…
The U.S. Food and Drug Administration has approved the oral therapy Lynparza (olaparib) for treating men with metastatic castration-resistant prostate cancer (mCRPC) who carry mutations in homologous recombination repair (HRR) genes, including BRCA or ATM. Approval is specific for men who failed prior treatment with Xtandi (enzalutamid) or Zytiga (abiraterone acetate), two hormone therapies. The decision was based on findings…
Scientists have discovered a gene signature in certain types of breast cancer that can be used to determine the likelihood of these tumors responding to treatment with a new class of anti-cancer medications known as Smac-mimetics. Triple-negative breast cancer (TNBC) was one of the best responders, suggesting these agents may be adopted as a new…
The U.S. Food and Drug Administration (FDA) has approved Genentech‘s Tecentriq (atezolizumab) as an initial treatment of people with metastatic non-small cell lung cancer (NSCLC) whose tumors produce high levels of the PD-L1 protein but have no alterations in the EGFR or ALK genes. Approval was based on findings from the IMpower110 Phase 3 trial (NCT02409342), which showed…
Maintenance therapy with AstraZeneca’s Lynparza (olaparib) extended survival by more than one year in women with BRCA-mutated relapsed ovarian cancer, whose tumors responded to platinum-based chemotherapy, final results from the SOLO-2 Phase 3 clinical trial show. Trial findings, “Final overall survival (OS) results from SOLO2/ENGOT-ov21: A phase III trial assessing maintenance olaparib in patients (pts)…
The U.S. Food and Drug Administration (FDA) has approved a combination of Opdivo (nivolumab) with low-dose Yervoy (ipilimumab) for the initial treatment of people with metastatic non-small cell lung cancer (NSCLC) whose tumors produce the PD-L1 protein. The approval is for those without alterations in the EGFR or ALK genes, and comes on the heels of promising…
The European Commission (EC) has approved Adcetris (brentuximab vedotin) when used alongside chemotherapy as a first treatment for adults with systemic anaplastic large cell lymphoma (sALCL), a type of peripheral T-cell lymphoma (PTCL). The decision to extend Adcetris’ current approval came after the Committee for Medicinal Products for Human Use (CHMP), a branch of the European…
Cassava Sciences‘s investigational therapy PTI-125 failed to significantly lower the levels of Alzheimer’s-relevant biomarkers present in fluid surrounding the brain and spinal cord of patients, according to results from a Phase 2b clinical trial. The company announced it will study these topline data in deciding next steps for PTI-125 as a potential treatment. Alzheimer’s disease…
The U.S. Food and Drug Administration (FDA) asked for more information from Bristol Myers Squibb and Bluebird Bio as it considers a request to approve their lead CAR T-cell therapy — idecabtagene vicleucel (ide-cel; bb2121) — for heavily pre-treated patients with multiple myeloma. The agency’s refusal letter requested further details on the potential therapy’s chemistry, manufacturing and control — or…
