trending Market Intelligence /marketintelligence/en/news-insights/trending/NzgM0phmGpX5n3lFTZdYfA2 content
Log in to other products

Login to Market Intelligence Platform

 /


Looking for more?

Contact Us

Request a Demo

You're one step closer to unlocking our suite of comprehensive and robust tools.

Fill out the form so we can connect you to the right person.

If your company has a current subscription with S&P Global Market Intelligence, you can register as a new user for access to the platform(s) covered by your license at Market Intelligence platform or S&P Capital IQ.

  • First Name*
  • Last Name*
  • Business Email *
  • Phone *
  • Company Name *
  • City *
  • We generated a verification code for you

  • Enter verification Code here*

* Required

Thank you for your interest in S&P Global Market Intelligence! We noticed you've identified yourself as a student. Through existing partnerships with academic institutions around the globe, it's likely you already have access to our resources. Please contact your professors, library, or administrative staff to receive your student login.

At this time we are unable to offer free trials or product demonstrations directly to students. If you discover that our solutions are not available to you, we encourage you to advocate at your university for a best-in-class learning experience that will help you long after you've completed your degree. We apologize for any inconvenience this may cause.

In This List

Blueprint's precision medicine for gastrointestinal tumors approved by US FDA

COVID-19 Pandemic Likely To Cause US Telemedicine Boom

Gauging Supply Chain Risk In Volatile Times

S&P Global Market Intelligence

Cannabis: Hashing Out a Budding Industry

Segment

IFRS 9 Impairment How It Impacts Your Corporation And How We Can Help


Blueprint's precision medicine for gastrointestinal tumors approved by US FDA

Blueprint Medicines Corp.'s targeted cancer drug Ayvakit has been approved by the U.S. Food and Drug Administration for treating certain gastrointestinal tumors that can not be surgically removed or have spread to other body parts.

Ayvakit is the first drug approved to treat patients with gastrointestinal stromal tumor, or GIST, who have a specific mutation of the platelet-derived growth factor receptor alpha, or PDGFRA gene, the U.S. regulator noted in a Jan. 9 release. Tumors with this mutation do not respond to the usual course of treatment.

GIST is a type of sarcoma or cancer that develops in the bone or connective tissue. These tumors grow in the wall of the gastrointestinal tract, most commonly in the stomach or small intestine. Most cases of GIST are caused by genetic mutations that force proteins into an active state.

The approval is based on results from a phase 1 clinical trial called Navigator, which showed a reduction of tumor size in 84% of patients with the PDGFR mutation.

Ayvakit, or avapritinib, blocks a particular enzyme and prevents the cancer cells from growing.

Cambridge, Mass.-based Blueprint Medicines plans to launch the drug in the U.S. market within a week, according to a press release. According to one doctor involved in the Navigator trial, the FDA's nod "represents a call to action" for GIST patients to be tested for this gene mutation to apply the precision medicine approach before other treatment is offered.

Blueprint Medicines' application for Ayvakit was broken down by the FDA into two parts in October 2019. The regulator expects to announce a decision regarding the second indication of the drug as a fourth-in-line treatment for GIST by Feb. 14.

The FDA has also granted Ayvakit breakthrough therapy designation for treating advanced systemic mastocytosis, a disorder in which mast cells accumulate in internal tissues and organs such as the liver, spleen, bone marrow and small intestines.