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| Pertuzumab to bolster Roche/Genentech's breast cancer franchise?
October, 2011
Nature Biotechnology
In July, Genentech announced that its humanized monoclonal antibody (mAb) drug pertuzumab met its primary endpoint in a phase 3 trial of metastatic breast cancer patients also receiving the standard regimen of Herceptin (trastuzumab) plus Taxotere (docetaxel). The company, a subsidiary of Basel-based Roche, has so far revealed few details on the outcome of the combination trial, dubbed Cleopatra. Its terse disclosure simply stated the combination “significantly” extended progression-free survival in women with HER2-overexpressing metastatic breast cancer. The safety profile was consistent with previous studies of the two drugs, either as monotherapy or in combination. But anticipation over the drug's efficacy is mounting because, if successful, the new combination could extend the benefits of targeted therapy to HER2-positive patients, who either do not respond to or relapse on existing Herceptin-based regimens.
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| Seattle Genetics rare cancer drug sails through accelerated approval
October, 2011
Nature Biotechnology
On August 19, Seattle Genetics of Bothell, Washington, received the nod from the US Food and Drug Administration (FDA) for its immunoconjugate drug Adcetris (brentuximab vedotin) in two rare cancers, relapsing Hodgkin's lymphoma and anaplastic large cell lymphoma (ALCL). The same month, FDA gave accelerated approval to Pfizer's Xalkori (crizotinib) for ALK-positive advanced non-small cell lung cancer. In addition to being good news for underserved patient populations, these approvals serve to quell fears that the FDA has raised the bar for accelerated approval, following the circus around Avastin (bevacizumab), Basel-based Roche's blockbuster monoclonal antibody (mAb).
In the case of Adcetris, accelerated approval will no doubt deliver a commercial advantage to Seattle Genetics.
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| New fee structure proposed by FDA might lead to more talk
October, 2011
Nature Medicine
Ever since 1992, when US lawmakers passed the Prescription Drug User Fee Act (PDUFA) to accelerate review of new drugs by the US Food and Drug Administration, industry money has had an increasingly important role in fueling the regulatory agency. In the program's first year, drug companies paid less than $9 million total to the FDA through the initiative. But in the past two decades the amount has ballooned; this year, the agency anticipates receiving at least $619 million in user fees, composing roughly 65% of its budget for overseeing human drugs.
Despite the torrent of funds, the FDA has still failed to meet its goal of completing the review of 90% of new drug applications within ten months. Industry isn't exactly pleased with this report card, and they have spent the past year in negotiations with the agency to plan how the fees can be used to make drug review more efficient.
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| Cancer drugs find a companion with new diagnostic tests
October, 2011
Nature Medicine
When Stephen Little co-founded a molecular diagnostics company in 2001, he gave numerous presentations to pharmaceutical companies touting the benefits of tests that can tell which patients are likely to respond to a particular therapy or experience side effects. But most drugmakers were focused on blockbusters, and, since these so-called 'companion diagnostics' divide patient populations into smaller groups, they threatened to contract, not expand, their markets. As such, Little recalls, “there was not a great deal of enthusiasm.”
Ten years later, the tide has changed for Little and the field of companion diagnostics. In 2009, Little's company, Manchester, UK–based DxS, was bought by the Dutch technology company Qiagen, where Little now serves as vice president of personalized health care.
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