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Lartruvo (olaratumab; Lilly) will be withdrawn from the market following results from the phase 3 ANNOUNCE study which showed that the treatment, when combined with doxorubicin, did not improve survival in patients with advanced or metastatic soft tissue sarcoma (STS) compared with doxorubicin alone.
Lilly is working to establish an access program to provide Lartruvo to patients who wish to continue treatment, after consultation with their physicians; new patients, outside of those in clinical trials, should not be initiated on Lartruvo.
“Lilly wants to ensure that patients and physicians feel supported during this important time,” said Anne White, president, Lilly Oncology. “Establishing this program will give patients who are currently taking Lartruvo the opportunity to continue their treatment program uninterrupted.”
Lartruvo is a platelet-derived growth factor receptor alpha (PDGFR-α) blocking antibody that specifically binds PDGFR-α and prevents receptor activation. It was granted accelerated approval in 2016 for the treatment of adult patients with STS with a histologic subtype for which an anthracycline-containing regimen is appropriate and which is not amenable to curative treatment with radiotherapy or surgery.
The continued approval of this indication was contingent upon verification and description of clinical benefit in the confirmatory trial. The ANNOUNCE study, however, did not meet the primary endpoints of overall survival in the full study population or in the leiomyosarcoma (LMS) sub-population.
Information regarding the access program will be provided directly to physicians by the Company in the coming weeks.
For more information visit Lilly.com.
