Lilly Breast Cancer Treatment Moves Forward

Posted: Updated:
INDIANAPOLIS -

Indianapolis-based Eli Lilly and Co. (NYSE: LLY) says the U.S. Food and Drug Administration has accepted the New Drug Application for a potential breast cancer treatment. The application for abemaciclib also received a Priority Review designation, which aims to expedite the approval process by regulators.

Lilly says the NDA includes submission of the potential treatment of advanced breast cancer both on its own and in combination with another drug known as fulvestrant. With the Priority Review designation, the FDA could give is approval or rejection of the drug within eight months instead of the standard 12.

"We are pleased that the FDA has granted abemaciclib Priority Review, both as a potential monotherapy and combination therapy [with fulvestrant] for patients with advanced breast cancer," said Levi Garraway, senior vice president of global development and medical affairs with Lilly Oncology. "Breast cancer is a complex disease, and the need still exists for new treatment options as patients face a significant disease burden. We look forward to working with the FDA and bringing this important potential treatment option to patients as soon as possible."

Lilly says it expects the FDA to make a ruling on the treatment in first quarter 2018. The company says it also intends to submit the treatment to European regulators in third quarter 2017 and to Japanese regulators before the end of this year.

Last week, Lilly announced it had received approval from Japanese regulators for its once-daily treatment of rheumatoid arthritis.

  • Perspectives

    • Sign Up For 'my Social Security' - It's a No-Brainer!

      Your current age or status doesn't matter. If you've earned a paycheck at some time in your life, keeping tabs on what the Social Security Administration shows you've earned just makes good sense. But does the thought of waiting in line at the Social Security office make you cringe? Then don't do it! Now there's another option...

    More

Subscribe

Name:
Company Name:
Email:
Confirm Email:
HTML
INside Edge
Morning Briefing
BigWigs & New Gigs
Life Sciences Indiana
Indiana Connections
INPower
Subscribe
Unsubscribe

Events



  • Most Popular Stories

    • Sign Up For 'my Social Security' - It's a No-Brainer!

      Your current age or status doesn't matter. If you've earned a paycheck at some time in your life, keeping tabs on what the Social Security Administration shows you've earned just makes good sense. But does the thought of waiting in line at the Social Security office make you cringe? Then don't do it! Now there's another option...

    • Opioid Withdrawal Treatment Lands FDA Clearance

      The U.S. Food and Drug Administration has given clearance for a medical device developed in Indiana to help treat symptoms of opioid withdrawal. The device, known as the NSS-2 BRIDGE, was created by Innovative Health Solutions Inc. in Versailles.

    • Coal Loading Facility Planned For Princeton

      A subsidiary of Denver-based Hallador Energy Co. (Nasdaq: HNRG) has announced plans to construct a new truck-to-rail coal loading facility near Princeton. Sunrise Coal LLC in Terre Haute says the facility, known as the Princeton Loop, is expected to be complete in the spring of 2018. 

    • Blackhawks, Bruins to Play at Notre Dame Stadium

      Notre Dame Stadium will be the site of a high-profile National Hockey League game next season. The league has announced the University of Notre Dame will host the 2019 Bridgestone NHL Winter Classic featuring the Chicago Blackhawks and Boston Bruins. Commissioner Gary Bettman expects the game to be the "largest live audience ever to witness a game by either of these teams." Notre Dame Stadium can hold some 80,000 fans, providing "an ideal setting..."

    • Hoosier Businesses Among 'Most Respected'

      Three Indiana companies are listed among their respective industries on an annual list for corporate reputation. The World's Most Respected Companies from FORTUNE are determined by nine factors that are voted on by executives from 680 companies in 28 countries. None of the businesses based in Indiana made FORTUNE's Top 50 "All-Star" list.