Zydus Lifesciences Limited and Dr. Reddy's Laboratories, a global pharmaceutical company, announced the execution of a licensing agreement to co-market Pertuzumab biosimilar in India. Pertuzumab is a critical treatment for HER2 positive breast cancer patients. The biosimilar has been developed in-house by the research team at the Zydus Research Centre (ZRC).
In a phase 1 clinical trial, the first human study of the pertuzumab biosimilar candidate HLX11(Shanghai Henlius Biotech), investigators found pharmacokinetic (PK) parameters, safety, and immunogenicity were similar to the US, EU, and China version of the reference product following a single dose in healthy male adults in China.
Swiss drugmaker Roche Pharma on Thursday said it has made the breast cancer antibody cocktail drug PHESGO available in India, which will be priced 20% less and more convenient to administer than the existing therapy. PHESGO is the world's first fixed dose combination of two monoclonal antibodies Perjeta (pertuzumab) and Herceptin (trastuzumab) in Oncology for the treatment of HER - 2 positive breast cancer. The drug is approved for treating both early and late stage or metastatic HER2-positive breast cancer.
Chugai Pharmaceutical Co., Ltd. announced that it obtained regulatory approval from the Ministry of Health, Labour and Welfare (MHLW) for the anti-HER2 humanized monoclonal antibodies, Perjeta for intravenous infusion 420mg/14 mL [generic name: pertuzumab] (Perjeta) and Herceptin for intravenous infusion 60 and 150 [generic name: trastuzumab] (hereafter, Herceptin), for the additional indication of advanced or recurrent HER2-positive colon cancer or rectal cancer not amenable to curative resection that has progressed after cancer chemotherapy.
Opdivo added to chemotherapy before surgery in the so-called neoadjuvant setting lowered the risk of tumor recurrence, progression or death in patients with resectable stage IB to IIIA non-small cell lung cancer, BMS said Monday.
The Christie NHS Foundation Trust has become the first cancer centre in the UK to offer the treatment Phesgo, developed by Roche’s Genentech division, for breast cancer at home.
EMA’s human medicines committee (CHMP) recommended five medicines for approval at its November 2020 meeting.
Roche’s Herceptin, like other larger cancer drugs in its portfolio, is under biosimilar assault. But with a new, easy-to-use combo product, the Swiss drugmaker may be able to defend its star against the copycats.
Basel, 29 June 2020 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the US Food and Drug Administration (FDA) has approved Phesgo™, a fixed-dose combination of Perjeta® (pertuzumab) and Herceptin® (trastuzumab) with hyaluronidase, administered by subcutaneous (SC; under the skin) injection in combination with intravenous (IV) chemotherapy, for the treatment of early and metastatic HER2-positive breast cancer. This is the first time that Roche has combined two monoclonal antibodies that can be administered by a single SC injection.
SILVER SPRING, Md., June 29, 2020 /PRNewswire/ -- Today, the U.S. Food and Drug Administration approved Phesgo—a combination of pertuzumab, trastuzumab and hyaluronidase–zzxf—for injection under the skin to treat adult patients with HER2-positive breast cancer that has spread to other parts of the body, and for treatment of adult patients with early HER2-positive breast cancer. Patients should be selected based on an FDA-approved companion diagnostic test.