Blueprint medicines7/14/2023 ![]() The FDA has accepted the MTC application for its Real-Time Oncology Review (RTOR) pilot programme, which aims to explore a more efficient review process to ensure safe and effective treatments are available to patients as early as possible. Blueprint Medicines has also submitted an NDA to the US FDA for RET mutation-positive MTC and RET fusion-positive thyroid cancer. The FDA granted priority review with an expected decision date of 23 November 2020. ![]() “With Roche’s global reach and unparalleled expertise in personalised healthcare, this collaboration will accelerate our ability to bring pralsetinib to patients with significant medical needs around the world and expand development of pralsetinib across multiple treatment settings where there is potential to benefit even broader patient populations,” said Jeff Albers, Chief Executive Officer of Blueprint Medicines.īlueprint Medicines has submitted a new drug application (NDA) for pralsetinib to the US Food and Drug Administration (FDA) and a marketing authorisation application to the European Medicines Agency (EMA) for the treatment of RET fusion-positive NSCLC. “In bringing pralsetinib to patients, we will leverage our global reach and expertise in oncology, as well as our capabilities in diagnostics and the use of real-world data toward our aim of providing personalised treatments for patients." “We are very excited to enter into this collaboration with Blueprint Medicines, a partner we have already been working with for four years, with the goal of bringing a potentially transformative treatment option to patients with rare RET-altered cancers as quickly as possible,” said James Sabry, Head of Roche Pharma Partnering. Beyond lung cancer, pralsetinib’s tumour-agnostic potential further expands Roche's ongoing commitment to finding new approaches to treat cancer in a more personalised way based on the genetic mutation of the disease, irrespective of the tumour site of origin. In lung cancer, pralsetinib will complement Roche’s broad portfolio of already approved medicines, alongside Alecensa, Rozlytrek, Tecentriq, Avastin and Tarceva and will further support our focus on understanding driver mutations in lung cancer through personalised treatment approaches. With the ongoing need for more targeted therapies that may offer clinical benefit to people with these types of cancers, this collaboration reflects Roche's strategy of providing treatments tailored specifically to a patient’s individual tumour profile and delivering truly personalised healthcare. RET-activating fusions and mutations are key disease drivers in many cancer types, including NSCLC and MTC, and treatment options that selectively target these genetic alterations are limited. The companies also plan to expand development of pralsetinib in multiple treatment settings and explore development of a next-generation RET inhibitor under the collaboration. In addition, pralsetinib has demonstrated tumour-agnostic potential. In the US, Genentech, a member of the Roche Group, will obtain co-commercialisation rights to pralsetinib, Blueprint Medicine’s investigational, once-daily oral precision therapy for the treatment of people with RET-altered non-small cell lung cancer (NSCLC), medullary thyroid cancer (MTC) and other types of thyroid cancer, as well as other solid tumours. Roche will pay an upfront of $675 million in cash in addition to a $100 million equity investment in Blueprint Medicines who is eligible to receive up to $927 million in potential milestones, plus royalties on net product sales outside the US.īasel, 14 July 2020 - Roche (SIX: RO, ROG OTCQX: RHHBY) and Blueprint Medicines Corporation (NASDAQ: BPMC), today announced the signing of a licensing and collaboration agreement providing exclusive rights to Roche for global co-development and commercialisation outside the United States (US), excluding Greater China*.Roche and Blueprint Medicines will co-commercialise pralsetinib in the US while Roche will be responsible for commercial activities outside the US, excluding Greater China*.Blueprint Medicines and Roche will collaborate on the development of pralsetinib.Roche will obtain co-development and co-commercialisation rights for pralsetinib, an investigational, precision therapy in late-stage development for people with RET-altered non-small cell lung cancer, various types of thyroid cancer and other solid tumours.
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