New PhIII data in hand, Pfizer, Astellas hustle ahead in bid to expand US market for Xtandi

Mace Rothenberg, Pfizer

Pfizer $PFE just got some badly needed good news for its newly acquired cancer drug Xtandi.

After watching sales sink right after it acquired the therapy and all of Medivation for $14 billion, researchers say the drug cleared the Phase III study for non-metastatic, castration resistant prostate cancer. And at least one prominent analyst says that’s a big deal as Pfizer and its partners at Astellas look to build sales for this key therapy.

Sticking with top line results only, the drug plus androgen deprivation therapy hit its mark on metastasis-free disease, compared to ADT alone.

Not surprisingly, the big pharma partners plan to hustle ahead in search of a label expansion for a new group of patients. And EvercoreISI’s Umer Raffat for one is enthusiastic about what this could mean on the revenue side. He noted:

The “PROSPER trial just added a brand new leg of growth + target population.  This eases investor concerns around consensus estimates which had Xtandi going from <$600M run rate in US now to $1B+ in 2020 amidst this evolving TRx trajectory in the existing indication.

“Many prostate cancer patients who initiate androgen deprivation therapy will experience disease progression illustrated by a rising PSA level, and currently, there are no FDA-approved treatment options for patients with non-metastatic CRPC until they develop confirmed radiographic metastatic disease,” said Neal Shore, director of the Carolina Urologic Research Center.

Pfizer’s cancer drug development chief Mace Rothenberg provided an encouraging cheer in a prepared statement. He said:

We are delighted with the significant results seen in the PROSPER study, showing that XTANDI plus ADT delayed clinically detectable metastases compared to ADT alone in patients with non-metastatic CRPC whose only sign of underlying disease was a rapidly rising prostate-specific antigen (PSA) level. We look forward to discussing the data with regulatory authorities.

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Sr. Manager, Regulatory Affairs, CMC
CytomX Therapeutics San Francisco, CA
Marketing Associate - Demand Generation
Catalytic Data Science Charleston, SC
Associate Principal, Life Sciences Partnerships
Flatiron Health New York City or San Francisco

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