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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 …


A market access strategy trifecta for Merck and Eisai

John G. Baresky

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 approved 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. The trifecta approval is an immediate market access victory for both companies as they can set forth with their launch and contracting strategies across three national markets at once.

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 reviews 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.

New drug approvals and the process of approving additional indications is a detail-heavy exercise necessary to qualify the performance and safety of medications. By improving the processes within nations and cultivating collaboration between them, patients and clinicians benefit from having access to approved therapies sooner.

For advanced medications, payers are often reluctant to cover their costs without specific regulatory approval of precise indications. Project Orbis initiatives help to overcome this hurdle.

For regulators of all nations, getting reviews and approvals completed sooner boosts efficiency and enables them to increase the volume of their work. While this works in favor of patients and medical professionals, it also helps biotech and pharmaceutical product manufacturers commercialize their products and recoup their costs sooner. This enables biotech and pharmaceutical enterprises to more effectively compete against one another.

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, 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.

Read about another success Merck has championed in Women’s Healthcare: HPV Vaccines: Oncology And STD Medical Breakthroughs

Although each nation approved the indication, they have their standards and interpretations as to how to communicate it to medical professionals in their countries. Brand, product and market access strategy elements all come into play as will training.

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.

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