It could be nothing, but it could be somthing.
Genentech has announced that it could have to wait up to three more months before it hears whether the FDA will approve its breast cancer drug Herceptin for patients in the early stages of the disease.
The FDA has asked for more time to review the dossier after Genentech submitted additional information which the agency has classified as a 'major amendment' to the file. It was originally due to rule on the application this Thursday.
The new information is a re-analysis of data from previously-submitted studies, said Genentech in a statement.At the moment, Herceptin (trastuzumab) is approved in the USA to treat tumours of the breast that express the HER-2 protein and have spread outside the breast, but Genentech wants to extend that indication to include the treatment of women with early-stage disease as an adjunct to surgery.
Roche, which holds a majority stake in Genentech, said Herceptin won approval in early HER-2-positive breast cancer in Europe in May. The Swiss drugmaker reported sales of 1.8 billion Swiss francs for Herceptin in the first six months of this year, while Genentech reported sales of $610 million for the drug in the same period.
The new submission is based on an interim analysis of more than 3,000 patients with early-stage breast cancer enrolled in two Phase III trials.
Hmmm. Insider wonders "why the procrastination by the FDA"?
And why the acquiessence by Genentech/Roche?
Roche's PR lackeys were very busy across the EU making sure drums were banged about this in Europe. Delays in treatment with this "wonder drug" were seen as unacceptable etc. etc.
But in the US.......... hmmm!
Source: PharmaTimes
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