| |NOVEMBER 20248MERCK'S KEYTRUDA BAGS EUROPEAN NOD FOR INDICATIONS IN GYNAECOLOGIC CANCERSTHERMO FISHER & TELANGANA GOVT TO SET UP BIOPROCESS DESIGN CENTREMerck, a leading pharmaceutical firm, stated that Keytruda (pembrolizumab), their anti-PD-1 therapy, has received approval from the European Commission (EC) for two additional uses in gynaecologic cancers. Keytruda has received initial approval for use alongside carboplatin and paclitaxel as the first-line treatment option for primary advanced or recurrent endometrial carcinoma in adult patients eligible for systemic therapy.The second approval is for Keytruda, along with chemoradiotherapy (CRT), for treating adults with FIGO 2014 Stage III-IVA locally advanced cervical cancer who have not had prior definitive therapy. Keytruda has now been given approval for a total of 30 uses in the EU, which include five specifically for gynaecologic cancers ­ three for endometrial cancer and two for cervical cancer."These Keytruda-based regimens have the potential to change the treatment paradigm for people with endometrial and cervical cancer, two of the most commonly diagnosed cancers among women in Europe," said Dr. Gursel Aktan, vice president, global clinical development, Merck Research Laboratories. "These approvals underscore the continued expansion of the use of Keytruda in diverse patient populations and treatment settings with utility of Keytruda ranging from earlier lines of therapy to treating advanced disease." The EC approvals stem from data in the phase 3 clinical trials NRG-GY018 (KEYNOTE-868) and KEYNOTE-A18 (ENGOT-cx11/GOG-3047), following positive recommendations from the Committee for Medicinal Products for Human Use in September 2024.In the study NRG-GY018/KEYNOTE-868, Keytruda with carboplatin and paclitaxel, then Keytruda alone, showed a significant and meaningful increase in progression-free survival (PFS) versus just chemotherapy. POThermo Fisher Scientific signed a Memorandum of Understanding (MoU) with the Telangana Government to set up a bioprocess design centre (BDC) in Genome Valley, Hyderabad. With a total area of 10,000 sq. ft., the bioprocess design center is scheduled to begin operations in early 2025. It will act as a model to speed up the creation and production of cutting-edge biotherapeutics in India and the Asia-Pacific area. The Center will have cutting-edge laboratories and education centers to support scientific studies.Telangana minister for IT&E, industries & commerce and legislative affairs, Duddilla Sridhar Babu, said, "The establishment of this bioprocess design centre reflects the state's progressive policies and collaborative approach to building a robust biopharma infrastructure. With over 1,800 companies, Telangana is leading the way in making India a global hub for biopharma innovation. We partner with Thermo Fisher, the world leader in serving science, which is a transformative initiative that will advance the future of healthcare." Shakthi Nagappan, director of lifesciences and pharma, Government of Telangana, stated, "This partnership with Thermo Fisher marks a significant milestone in our efforts to build a first-of-its-kind bioprocessing facility for biologics manufacturing in India. The centre, featuring single-use bioreactors, will enhance the biopharma sector by offering pay-per-use infrastructure, technical expertise, and cutting-edge research solutions, helping companies reduce their time to market. It will not only drive the growth of biopharma manufacturing in Telangana but also bolster India's position on the global map". POTOP STORIES
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