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…
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…
Adding Erleada (apalutamide) to androgen deprivation therapy (ADT) significantly extends the lives of men with non-metastatic castration-resistant prostate cancer (CRPC) by more than one year, a final analysis of the SPARTAN Phase 3 clinical trial shows. Representing a 22% reduction in the risk of death in men at high risk of developing metastasis, the findings add…
The Swiss Agency for Therapeutic Products (Swissmedic) has approved Seattle Genetics‘ Tukysa, in combination with trastuzumab and Xeloda (capecitabine), for the treatment of patients with metastatic HER2-positive breast cancer. Tukysa is now approved for individuals who have been treated previously with at least two other anti-HER2 therapies, examples of which include Kadcycla (ado-trastuzumab emtansine), Perjeta (pertuzumab), and trastuzumab (sold under the brand name Herceptin,…
Zejula (niraparib) given in combination with Avastin (bevacizumab) shows promising safety and efficacy at delaying disease progression in women with advanced ovarian cancer who had responded to a first-line platinum-based chemotherapy plus Avastin, interim results from a Phase 2 trial show. These findings are in the presentation, “Phase II OVARIO study of niraparib + bevacizumab therapy…
