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… Project Orbis is a collaboration of the United States, Australia and Canada to drive advancement in Oncology therapeutic development and approvals …

Oncology initiatives in Women’s Healthcare have gained another valuable therapy to improve patient care and outcomes…

Merck & Co.’s ( NYSE: MRK )Keytruda and combination partner therapy Eisai’s ( OTCMKTS: ESALY ) Lenvima will keep their respective marketing and sales units very busy in the upcoming months. Regulatory agencies in the United States, Canada and Australia have concurrently approval to the Keytruda-Lenvima tandem for women with certain advanced endometrial carcinoma. It represents a significant accomplishment by Merck and Eisai and for government regulatory agencies working together to accelerate the process of advancing medicine whether it’s for completely new products or clinically strategic new indications.

Project Orbis…

The parallel decisions are the first made through Project Orbis ;a collaborative initiative of the Food And Drug Administration ( FDA ), the Australian Therapeutic Goods Administration ( TGA ) and Health Canada that seeks to reduce new oncology therapy review turnaround between nations. It champions concurrent submissions by drug manufacturers and collaborative assessments by each of the three government regulatory agencies, sponsors and collaborative reviews by all three agencies.

Women’s Healthcare and oncology…

The approval is centered on Women’s Healthcare and endometrial cancer that’s not microsatellite instability high (MSI-H) or mismatch repair deficient (dMMR) and for patients whose tumors have progressed following prior treatment. Keytruda has FDA approval as a monotherapy for MSI-H or dMMR cancers; its approval in that specific indication is the first time the FDA approved a drug based on a biomarker rather than tumor location ( known as tissue-agnostic therapy ).

According to the FDA and other Women’s Health authorities, Endometrial cancer is the most common cancer of the female genital tract and based on comments from Eisai oncology chief discovery officer Takasha Owa at least 75% are not MSI-H or dMMR, T.

Merck, Eisai: a clinical and commercial collaboration…

Merck, based in Kenilworth, New Jersey and Eisai, based in Bunkyo City, Tokyo, Japan will have busy marketing and sales units deeply engaged in facilitating the communication of the new indication in the respective oncology and ob/gyn markets of the United States, Australia and Canada. Although each nation approved the indication, they have their own standards and interpretations as to how to communicate it to medical professionals in their countries. Brand, product and digital marketing elements all come into play as will training.

Moving forward…

Based on the success of the Keytruda and Lenvima reviews, it is hoped the streamlined Project Orbis approval process can deliver success with other oncology therapy reviews, new drug and new indication approvals. Time is an irreplaceable resource and a pivotal factor in healthcare. For Women’s Healthcare and Oncology medical professionals, they need to gain every advantage possible to increase patient care and drive successful patient outcomes.

Thank you for reading this article. Check out my other stories about therapeutic advances, healthcare technology, healthcare digital marketing, healthcare social media strategy plus my industry website:

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John G. Baresky


John G. Baresky Healthcare Marketing Guy

About me…

I lead healthcare marketing initiatives in competitive sectors spanning pharmaceutical, medical device technology, clinical programs, health services, healthcare RPA ( robotic process automation ), software, SaaS and managed care. I am from a healthcare family ( 20+ credentialled medical professionals ) and have 20+ years experience in the healthcare industry advancing patient care and achieving commercial goals.

· Numerous medical specialties and sectors including ​hospital, health system, IDN, MTF, surgery center, LTC, dialysis, oncology, pharmacy ( retail, mail, compounding, specialty ), GPO, distributor, wholesaler, consumer / patient, employers, benefit consulting and payers ( MCO, BCBS, PBM, Medicaid, Medicare, DHA / TRICARE )

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