Updated interim data from a Phase 1 clinical trial continues to support the safety and anti-tumor activity of Sutro Biopharma’s STRO-002 for heavily pre-treated women with advanced ovarian cancer. About one-quarter of patients receiving a dose of 2.9 mg/kg or higher responded to this investigational antibody-drug conjugate, and nearly half (44%) had responses lasting at least 16 weeks, results showed.…
ONCOTracker and The Binding Site have entered an agreement to develop and commercialize a new test that measures serum levels of the B-cell maturation antigen (sBCMA) protein to monitor people with blood cancers, including multiple myeloma. Under the agreement, The Binding Site has gained exclusive rights to commercialize this test worldwide. ONCOTracker, which has patented…
When given alongside endocrine therapy (ET), Verzenio (abemaciclib) can lower the risk of cancer recurrence and spread compared to standard ET alone in patients with certain forms of early breast cancer who have a high risk of seeing their disease return and spread elsewhere, according to results from a Phase 3 trial. Data from the study’s…
Adding Takeda’s Ninlaro (ixazomib) to Revlimid (lenalidomide) and dexamethasone failed to significantly extend life without disease progression in people newly diagnosed with multiple myeloma who are ineligible for autologous stem cell transplant, top-line data from a Phase 3 clinical trial show. Still, Ninlaro’s triple combination was significantly superior to the Revlimid-dexamethasone combo at promoting profound treatment…
Tecentriq (atezolizumab), in combination with Avastin (bevacizumab), has been recommended for approval in the European Union as a first-line treatment for adults with advanced hepatocellular carcinoma (HCC), the most common form of liver cancer. The recommendation was made by the Committee for Medicinal Products for Human Use (CHMP), an arm of the European Medicines Agency. The…
A first patient has been dosed in a Phase 1 clinical trial investigating the small molecule inhibitor EPI-7386 as a treatment for metastatic castration-resistant prostate cancer (CRPC), its developer, ESSA Pharma, reported. Metastatic CRPC is prostate cancer that has metastasized, or spread to distant regions, and is resistant to traditional treatments that lower levels of androgen hormones,…
Lynparza (olaparib), in combination with bevacizumab, has been recommended for approval in the European Union (EU) as a first-line maintenance therapy for women with advanced ovarian cancer positive for homologous recombination deficiency (HRD) and who responded to platinum-based chemotherapy. The positive opinion released by the Committee for Medicinal Products for Human Use (CHMP), an arm of the European Medicines Agency, also includes…
The first participant has been enrolled in a Phase 2 clinical trial evaluating the safety and efficacy of GDC-9545 in combination with palbociclib as an investigational treatment for postmenopausal women with estrogen receptor (ER)-positive and HER2-negative untreated early breast cancer. “The initiation of enrolment is an important milestone as we aim to better understand the activity and safety of this…
The U.S. Food and Drug Administration (FDA) has granted priority review to Bristol Myers Squibb and Bluebird Bio‘s application requesting the approval of idecabtagene vicleucel (ide-cel) for the treatment of adults with multiple myeloma. The biologics license application (BLA), resubmitted in August, is seeking ide-cel’s approval for myeloma patients who failed to respond to at least three prior lines…
A European Medicines Agency (EMA) committee has recommended that a combination therapy of Opdivo (nivolumab) and Yervoy (ipilimumab) plus two cycles of platinum-based chemotherapy be approved in the European Union (EU) as first-line treatment for advanced non-small cell lung cancer (NSCLC). The EMA’s Committee for Medicinal Products for Human Use (CHMP) recommended the approval specifically for adults whose tumors contain no mutations in the…
