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: Improve accuracy and accelerate new drug and indication approvals across multiple nation government agencies... 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. Project Orbis: A winning initiative for patients and clinicians New drug approvals and the process of approving additional indications is a detail heavy exercise necessary to qualify 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 medication, payers are often reluctant to cover their costs without specific regulatory approval of precise indications. Project Orbis initiatives helps to overcome this hurdle. Read the article for complete details and contact John Baresky for further information...

1. … Project Orbis is a collaboration of the United States, Australia and Canada to drive advancement in
Oncology therapeutic development and approvals …
MERCK KEYTRUDA AND EISAI
LENVIMA ACHIEVE TRIPLE
APPROVAL
John G. Baresky 9/25/19
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.

2. 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: Improve accuracy and accelerate new drug and
indication approvals across multiple nation government agencies
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.
Project Orbis: A winning initiative for patients and clinicians
New drug approvals and the process of approving additional indications is a
detail heavy exercise necessary to qualify 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 medication, payers are
often reluctant to cover their costs without specific regulatory approval of
precise indications. Project Orbis initiatives helps to overcome this hurdle.
Project Orbis: A winning initiative for government regulators, biotech
and pharmaceutical companies
For regulators of all nations, getting reviews and approvals completed
sooner boosts efficiency and enables them to increase the volume of their
work.

3. While this works in favor of patients and medical professionals, it also helps
biotech and pharmaceutical product manufacturers commercialize their
products sooner so they can begin to recoup the costs of their expenses
invested in developing new products as well as researching their potential
for additional indications by conducting more clinical trials and generating
more data after initial approvals are completed. This also enables biotech
and pharmaceutical enterprises to more effectively compete against one
another.
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.
Read about another success Merck has championed in Women’s
Healthcare: HPV Vaccines: Oncology And STD Medical Breakthroughs

4. 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
healthcare mergers and acquisitions, clinical and commercial
developments, medical technology, healthcare brand and product
management, digital marketing strategy, social media and market
access strategy…
About me
I lead healthcare marketing initiatives spanning pharmaceutical, medical
device technology, clinical programs, health services, healthcare RPA (
robotic process automation ), software, SaaS and managed care. My
background covers team building, digital marketing, brand and product
management, content development, content marketing, upstream and
downstream marketing and market access strategy.
Connect with me at LinkedIn, Twitter, Email or my website
LinkedIn:
John G. Baresky

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