Conditions

The U.S. Food and Drug Administration (FDA) has accepted and given priority review to Merck‘s application requesting the approval of Keytruda (pembrolizumab) as a second-line treatment for adults with relapsed or refractory classical Hodgkin’s lymphoma (cHL). The supplemental biologics license application was based on data from the Phase 3 KEYNOTE-204 clinical trial (NCT02684292), in which Keytruda significantly…

Adding Imfinzi (durvalumab) to standard first-line chemotherapy prolongs survival for adults newly diagnosed with inoperable malignant pleural mesothelioma, according to data from a Phase 2 clinical trial. This study is the first to show survival times exceeding 20 months in this patient population. A Phase 3 trial, called DREAM3R (NCT04334759), to confirm the combination’s superiority over…

The European Medicines Agency (EMA) has agreed to review a request to approve the investigational CAR T-cell therapy, lisocabtagene maraleucel (liso-cel), for people with pretreated lymphomas. The marketing authorization application, submitted by Bristol Myers Squibb, is specific to patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), primary mediastinal B-cell lymphoma (PMBCL), and follicular lymphoma…

Oncopeptides has submitted a new drug application to the U.S. Food and Drug Administration (FDA) requesting the accelerated approval of melflufen (melphalan flufenamide) plus dexamethasone for hard-to-treat patients with multiple myeloma. The application is specific for people with triple-refractory disease — those who failed to respond to at least one immunomodulatory agent (IMiD), one proteasome inhibitor, and one anti-CD38 monoclonal…

When given in combination with Kyprolis (carfilzomib), the investigative therapy Reolysin (pelareorep) elicits a strong inflammatory response — and promising clinical responses — in people with relapsed or refractory multiple myeloma, a Phase 1b trial shows. The study’s findings were presented in a poster, titled “Oncolytic virus Pelareorep plus Carfilzomib & Dexamethasone phase I trial in Carfilzomib-refractory patients…

A computer program developed by GNS Healthcare could be used to model and predict disease progression and response to treatment in people with multiple myeloma. Called “Gemini, the in silico ” Patient” (“in silico” refers to analyses done using computer simulation), the program was built through a collaboration between multiple biopharmaceutical companies, academic medical centers, and…

An office of the U.S. Food and Drug Administration (FDA has recommended that belantamab mafodotin, GlaxoSmithKline’s investigational antibody-drug conjugate, be approved for heavily pretreated relapsed or refractory multiple myeloma patients. The recommendation by the FDA’s  Oncologic Drugs Advisory Committee is for patients who had at least four prior lines of treatment, including an immunomodulatory agent, a proteasome inhibitor,…

A small inhibitor that prevents cells from making ribosomes — the machinery used to produce proteins — may improve the effectiveness of PARP inhibitors in ovarian cancers with mutations in DNA repair genes, a study in mice found. This inhibitor is a promising approach for ovarian cancers that are no longer susceptible to platinum-based chemotherapy or PARP…

China’s regulatory agency has agreed to consider a request that pamiparib, BeiGene‘s investigational PARP inhibitor, be approved to treat people with advanced ovarian cancers after at least two prior lines of chemotherapy. The company’s new drug application (NDA), submitted to the Center for Drug Evaluation of the Chinese National Medical Products Administration, is specifically for patients with…

China’s regulatory agency has granted priority review status to BeiGene‘s new drug application (NDA) requesting the approval of pamiparib, its investigational PARP inhibitor, for the treatment of advanced ovarian cancers. Priority review is granted in China to reduce the time to review and approve promising therapies that address urgent clinical needs. The NDA specifically covers patients with advanced ovarian, fallopian…

Second-line treatment with a combination of bevacizumab plus the chemotherapies carboplatin and pegylated liposomal doxorubicin may significantly improve the outcomes of platinum-sensitive ovarian cancer patients, compared to standard treatment, findings from a Phase 3 trial suggest. Women who received this experimental combination in the ENGOT-ov18 trial (NCT01837251) lived significantly longer without disease progression and experienced…

Tests used in clinical trials of ovarian cancer to determine if tumors lack the ability to repair their DNA — a status termed “homologous recombination deficiency” (HRD), and likely would respond to treatment with PARP inhibitors — yield inconsistent results, a recent study shows. Study findings were presented in the poster “Comparison of genomic instability test…