As the weather heats up in the western hemisphere, the temperatures are not the only thing increasing…
In Pharmaland, the oncology space traditionally sees either interesting new data published or a spate of post American Society of Clinical Oncology (ASCO) filings. The summer doldrums often give way to a faster pace in the fall.
One thing we have been following over the last two years is the T790M race to market in EGFR mutant lung cancer. Clovis Oncology announced last week that they have begun their rolling NDA submission for rociletinib (CO–1686), but what about their keen rival, AstraZeneca with AZD9291?
The company presented new data for AZD9291 jn the EGFR mutant lung cancer upfront setting, but no formal announcement was made about the regulatory status.
There are some potentially interesting new developments to report here, though.
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With the collapse of the Dendreon share price today following poor sales data (Adam Feuerstein on The Street has an excellent write up about this), attention has again focused on the prostate cancer market.
Zytiga (abiraterone acetate) was recently approved by the European Medicines Agency (EMA), following FDA approval earlier this year.
The EMA Committee for Medicinal Products for Human Use granted the marketing authorization for Zytiga at it’s July 2011 meeting. The approval noted,
“The poor prognosis of the target patient population represents a high unmet medical need while the novel mechanism of action of abiraterone has the potential to offer an alternative therapeutic option for these patients.”
What does this mean for sales of sanofi-aventis’ cabazitaxel (Jevtana), which was approved in Europe earlier this year?
Given that both drugs have approval in the same indication for metastatic castrate resistant prostate cancer (mCRPC) post-docetaxel chemotherapy, and the price is likely to be comparable, my guess would be that Jevtana sales will take a big hit.
After a sick prostate cancer patient has undertaken several cycles of chemotherapy with docetaxel, why would they not want to take an oral pill as opposed to another chemotherapy drug, which does have a less than stellar adverse-event profile. The answer is they will probably take a chemo-holiday and use Zytiga.
Jevtana simply came to the market too late in Europe, and Zytiga gained accelerated approval. It’s a reminder that we live in a dynamic pharmaceutical market place, as the news last night from Dendreon has also reminded us.