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FeDeriCa clinical trial results : Phase 3 trial in HER2-positive breast cancer meets primary endpoint

FeDeriCa clinical trial results : Phase 3 trial in HER2-positive breast cancer meets primary endpoint

FeDeriCa clinical trial results : Roche’s Genentech reported that the phase 3 FeDeriCa study evaluating the investigational fixed-dose combination (FDC) of Perjeta (pertuzumab) and Herceptin (trastuzumab) with hyaluronidase in HER2-positive breast cancer met its primary endpoint. The Perjeta and Herceptin combination, which was subcutaneously injected in combination with intravenous (IV) chemotherapy, showed non-inferior levels of […]

Puma secures FDA orphan drug status for NERLYNX in breast cancer with brain metastases

US biotech company Puma Biotechnology has secured orphan drug designation to NERLYNX (neratinib) from the US Food and Drug Administration (FDA) for the treatment of breast cancer patients having brain metastases, as per the latest pharma regulatory news. The FDA orphan drug designation program is given to investigational drugs designed for the treatment, prevention, or […]

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Imago Systems, Mayo Clinic to advance ICE Reveal for breast imaging

US medical imaging company Imago Systems and Mayo Clinic have signed a know-how license agreement to collaborate on breast imaging with the academic medical center to support clinical trial development and oversee the former’s reader studies for mammography. The multi-year agreement signed by the parties will focus on clinical trial support for the ICE Reveal […]

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MONARCH 2 clinical trial results : Verzenio, fulvestrant combo improves overall survival in metastatic breast cancer

MONARCH 2 clinical trial results : Eli Lilly and Company (Lilly) said that Verzenio (abemaciclib) in combination with fulvestrant delivered a statistically significant improvement in overall survival in the phase 3 MONARCH 2 clinical trial held for a type of metastatic breast cancer. The US pharma giant said that the MONARCH 2 clinical trial results […]

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Pharma giants bag Lynparza EMA approval for metastatic breast cancer

Lynparza EMA approval : Pharma giants AstraZeneca and MSD have secured an expansion of the European Medical Agency’s (EMA) approval for their poly ADP-ribose polymerase (PARP) inhibitor Lynparza (olaparib) to be used for the treatment of a type of advanced breast cancer. The expanded Lynparza EMA approval allows the PARP inhibitor to be used as […]

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Genentech gets Kadcyla FDA approval for post-surgery treatment of HER2+ EBC

Kadcyla FDA approval : Roche subsidiary Genentech has secured approval from the US Food and Drug Administration (FDA) for its breast cancer drug Kadcyla (ado-trastuzumab emtansine) for post-surgery treatment of HER2-positive early breast cancer (EBC) in patients with residual invasive disease who were subjected to before surgery taxane and Herceptin (trastuzumab)-based treatment. The Kadcyla FDA […]

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Ibrance FDA approval : Pfizer breast cancer drug approved for metastatic breast cancer in men

New Ibrance FDA approval : The US Food and Drug Administration (FDA) has extended the approval of Pfizer breast cancer drug Ibrance (palbociclib) to cover the treatment of hormone receptor positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer in male patients. Latest Ibrance FDA approval Under the new indication approved […]

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Novartis breast cancer drug Kisqali plus endocrine therapy extends PFS

Novartis breast cancer drug Kisqali (ribociclib) plus endocrine therapy has succeeded in extending progression-free survival (PFS) compared to only endocrine therapy in three phase 3 MONALEESA trials. The findings come from the Swiss pharma company’s release of data from subgroup analyses of the three pivotal trials in pre-, peri- and postmenopausal women, irrespective of the […]

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Oncternal begins phase 1b trial of breast cancer drug cirmtuzumab and paclitaxel combo

US oncology company Oncternal Therapeutics said that the first patient enrolled in a phase 1b trial of its investigational breast cancer drug cirmtuzumab in combination with paclitaxel, a standard-of-care chemotherapy drug, has been dosed. The phase 1b trial is evaluating the anti-ROR1 monoclonal antibody cirmtuzumab combination with paclitaxel, in breast cancer patients who are negative […]

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Lilly’s breast cancer drug abemaciclib meets objective in phase 3 trial

Indianapolis-based Lilly has reported that its breast cancer drug, abemaciclib, in combination with fulvestrant, has yielded positive results by meeting its primary endpoint, progression-free survival (PFS) in a phase 3 breast cancer trial. The combination of Lilly breast cancer drug abemaciclib with fulvestrant was proved to be more effective than the fulvestrant plus placebo combination […]

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