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Ortho Biotech's Yondelis In Ovarian Cancer Test Case For Progression Free Survival Endpoint

This article was originally published in The Pink Sheet Daily

Executive Summary

FDA's Oncologic Drug Advisory Committee also will evaluate the firm's Doxil in combination with docetaxel for locally advanced or metastatic breast cancer.

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Surrogate Endpoints Don't Convince ODAC: Panel Votes No On Two Centocor/Ortho Biotech Drugs

ODAC votes 14-1 against Yondelis in combination with Doxil for ovarian cancer, and 13-0 against Doxil in combination with docetaxel for metastatic breast cancer.

Surrogate Endpoints Don't Convince ODAC: Panel Votes No On Two Centocor/Ortho Biotech Drugs

ODAC votes 14-1 against Yondelis in combination with Doxil for ovarian cancer, and 13-0 against Doxil in combination with docetaxel for metastatic breast cancer.

Progression-Free Survival Represents Clinical Benefit, But How Much? – ODAC

While the Oncologic Drugs Advisory Committee generally endorses the idea that progression-free survival can support full approval of first-line therapies in metastatic breast cancer, the panel left FDA with the challenge of qualifying how PFS represents clinical benefit and determining the measure's meaningfulness for regulatory purposes

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