Four Special Channels for FDA to Review Drugs - PowerPoint PPT Presentation

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Four Special Channels for FDA to Review Drugs

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Recently, the FDA awarded the patent-based enfortumab vedotin antibody-conjugated drug developed jointly by Seattle Genetics and its partner Astellas. The drug is currently in a phase II study of a key metastatic transitional cell carcinoma. This is undoubtedly a good news for Seattle Genetics. They have also marked the project with a "breakthrough therapy" label. After the first commercial product, Adcetris, this is the company's most promising ADC drug. Enfortumab vedotin consists of an anti-Nectin-4 monoclonal antibody and Seattle's own synthetic cytotoxin monomethyl auristatin E (MMAE), which is the first ADC drug to target solid tumor Nectin-4, targeting bladder cancer. – PowerPoint PPT presentation

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Title: Four Special Channels for FDA to Review Drugs


1
Four Special Channels for FDA to Review Drugs
www.creative-biolabs.com/adc
2
01 Fast Track
02 Priority Review
Content
03 Accelerated Approval
04 Breakthrough Therapies
3
Backgournd
Recently, the FDA awarded the patent-based
enfortumab vedotin antibody-conjugated drug
developed jointly by Seattle Genetics and its
partner Astellas. The drug is currently in a
phase II study of a key metastatic transitional
cell carcinoma. This is undoubtedly a good news
for Seattle Genetics. They have also marked the
project with a "breakthrough therapy" label.
After the first commercial product, Adcetris,
this is the company's most promising ADC drug.
Enfortumab vedotin consists of an anti-Nectin-4
monoclonal antibody and Seattle's own synthetic
cytotoxin monomethyl auristatin E (MMAE), which
is the first ADC drug to target solid tumor
Nectin-4, targeting bladder cancer.
4
01
Fast Track
Fast-track refers to an accelerated review of
drugs for the treatment of serious illnesses and
to fill in unmet medical needs. Its purpose is to
enable patients to acquire important new drugs as
soon as possible. Fast-track access must be
initiated by pharmaceutical companies and can be
made at any stage of drug development. The FDA
will give a response within 60 days by judging
whether the drug meets the requirements.
5
02
Priority Review
A Priority Review designation will direct overall
attention and resources to the evaluation of
applications for drugs that, if approved, would
be significant improvements in the safety or
effectiveness of the treatment, diagnosis, or
prevention of serious conditions when compared to
standard applications.
6
03
Accelerated Approval
When studying a new drug, it can sometimes take
many years to learn whether a drug actually
provides a real effect on how a patient survives,
feels, or functions. A positive therapeutic
effect that is clinically meaningful in the
context of a given disease is known as clinical
benefit. Mindful of the fact that it may take an
extended period of time to measure a drugs
intended clinical benefit, in 1992 FDA instituted
the Accelerated Approval regulations. These
regulations allowed drugs for serious conditions
that filled an unmet medical need to be approved
based on a surrogate endpoint. Using a surrogate
endpoint enabled the FDA to approve these drugs
faster.
7
04
Breakthrough Therapy
Breakthrough therapies are generally filed by
pharmaceutical companies. FDA can also consider
proposals based on initial clinical results of
drugs and promotion of project promotion.
Applications for breakthrough therapies are
usually no later than the end of the second
phase, and the FDA will respond within 60 days.
Once a drug is approved for breakthrough
therapies, it will receive all rapid approval
policy benefits, and at the same time, it will
receive enhanced guidance from the FDA's
higher-level review team from the beginning of
the first phase of clinical trials.
8
Established in 2004, Creative Biolabs is highly
specialized in advanced antibody biochemistry and
engineering. With more than a decade of
exploration and expansion, our current research
and service capacity covers the entire new drug
discovery and development pipeline, ranging from
early discovery, antibody design, pre-clinical
evaluations, cGMP manufacturing, to clinical
trials. As an international cooperation, we have
established offices all around the globe with
more than 200 well-trained full-time scientists
and technicians, who work closely with our
customers and research partners to develop new
medicines for a better, healthier world. After
years of pursuit for perfection, Creative Biolabs
has established our leadership in targeted
immunotherapy and antibody-drug conjugate (ADC)
development.
Creative Biolabs
9
Contact Us
45-1 Ramsey Road, Shirley, NY 11967, USA
Email marketing_at_creative-biolabs.com
10
Thank you
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