Facilitating Collaborations to Develop Combination Investigational Cancer Therapies Workshop Summary (2012) / Chapter Skim
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7 Regulatory Issues
7 Regulatory Issues
Pages 55-62
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From page 55... ...
Dr. Robert Temple, deputy center director for clinical science at FDA's CDER, added that "the whole idea of how you demonstrate the contribution of a combination has historically been more flexible than people imagine," and said that the agency is currently working on clarifying its rule for combination products so it can be interpreted more flexibly.
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From page 56... ...
Suggestions from Various Workshop Participants to Address Regulatory Challenges • F ocusing on combinations with a compelling biological rationale and strong preclinical data • S eeking dialogue with FDA early in the development pro cess, and frequently as development progresses • E stablishing more dialogue between FDA and the Euro pean Medicines Agency, to enhance harmonization of regulations • O btaining more clarification from FDA regarding the types and levels of evidence needed for combination therapies • G etting better guidance from FDA on how sponsors should best interact with multiple FDA offices involved in combination product development FDA DRAFT GUIDANCE FDA recently released a draft guidance for industry on the codevelopment of two or more unmarketed investigational drugs for use in combination.1 At the conference, Drs. Sherman and Temple discussed the major premises on which this guidance is based.
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From page 57... ...
Dr. Pazdur responded by saying that a clinical trial with four separate arms was not going to be needed to show the rationale for combining drugs, but rather compelling preclinical information or results from Phase II trials or related information, such as relevant information about other members of the drug class that are already approved.
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From page 58... ...
Pazdur responded, "That's difficult to answer because it depends on the safety of the drug as well as what available therapies are around to treat that condition, and what endpoints they have been approved on or have shown in clinical practice." EFFECT OF COMBINED TOXICITY ON SINGLE-AGENT APPROVAL Dr. Schlom said that a major industry concern is that if two drugs that show minimal toxicity in Phase II or III trials are combined and then elicit major toxicity, neither drug will be approved by FDA as single agents.
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From page 59... ...
This is a basic tenet of how the agency functions, and it applies here." Dr. Pazdur stressed that for cancer treatments, efficacy is the major hurdle to cross, not toxicity, because FDA accepts a high degree of toxicity for cancer treatments and thus excessive concern about this issue is unwarranted.
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From page 60... ...
"I really couldn't understand why people wanted to marry their new drug that had very impressive response rates or potentially a survival advantage with a relatively ineffective drug," he said. COORDINATION OF DIAGNOSTIC AND THERAPEUTIC REGULATION Another regulatory challenge for combination therapy is the coordi nation between the different divisions in the FDA when diagnostic devices and drugs are used in the same clinical trial.
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From page 61... ...
Dr. Dagher added that "whether it's combinations or not, drug development is a global activity." He said that the only guid ance available from the European Medicines Agency (EMA)
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From page 62... ...
that don't in Europe." The FDA draft guidance is mainly for small molecules and not for vaccines and other products.
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