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news.The European Medicines Agency (EMA) has validated two of Bristol-Myers Squibb's type II variation applications, which seek to extend the current indication for its Immuno-Oncology agent, Opdivo.
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The company noted that validation of the applications confirms that the submissions are complete and starts the EMA’s centralized review process.
In lung cancer, the proposed new indication addresses the non-squamous NSCLC population — Opdivo as monotherapy to treat locally advanced or metastatic non-squamous NSCLC after prior chemotherapy in adults, while in melanoma, it aims to extend the use of Opdivo monotherapy in combination with Yervoy to treat advanced melanoma.
Bristol-Myers Squibb Oncology Development head and senior vice-president Michael Giordano said: "The starting of the EMA’s centralized review process marks a significant milestone in our commitment to make Opdivo available for a broader range of appropriate patients with advanced melanoma and lung cancer in Europe.
"Today’s announcement also is a step forward in realizing our vision to change survival expectations, transform the standard of cancer care, and the way patients live with cancer across multiple tumor types. We look forward to working with the EMA during its review process."
The type II variation submitted to the EMA in non-squamous NSCLC is based on data from the Phase III CheckMate -057 trial, which evaluated the survival of patients with advanced non-squamous NSCLC who had progressed during or after one prior platinum doublet-based chemotherapy regimen.
The type II variation application in advanced melanoma is based on data from two trials CheckMate -067 and CheckMate -069.
The Phase III CheckMate -067 trial evaluated the Opdivo+Yervoy regimen or Opdivo monotherapy vs. Yervoy monotherapy in adults with previously-untreated advanced melanoma.
The first randomized Phase II CheckMate -069 trial is evaluating the Opdivo+Yervoy regimen in patients with previously-untreated advanced melanoma, as well as supportive data from the Phase Ib CA209004 trial in advanced melanoma.
The company has submitted two separate marketing authorization applications (MAA), one in advanced melanoma under the tradename Opdivo and one for squamous NSCLC under the tradename Nivolumab BMS to accelerate availability of nivolumab for health care professionals in both indications.