Pharmacyclics, J&J get FDA shortcut for cancer drug

The classification of ibrutinib as a breakthrough therapy could mean speedy approval by the agency.

By Minyanville.com Feb 13, 2013 1:45PM
Doctor sitting in office with patient talking and smiling copyright Paul Bradbury, OJO Images, Getty ImagesPharmacyclics (PCYC) says its experimental drug for a pair of rare blood cancers received a new designation from U.S. officials that potentially sets it up for a quick approval. The news sent Pharmacyclics shares higher Wednesday.

Pharmacyclics and development partner Johnson & Johnson (JNJ) won the classification "breakthrough therapy" by the Food and Drug Administration for the oral drug ibrutinib as a single treatment for two cancers. That means the FDA will accept early clinical evidence showing that the drug is a big improvement over existing treatments.

Hopes for approval of the drug are already high. Shares of Pharmacyclics are up more than 200% in the past year and the company has amassed a $5 billion market cap. The stock rose another 7% to $75.24 in early trading Wednesday. Shares of Johnson & Johnson were little changed at $75.72 in morning trading. That stock is up 17% over the past year.

The companies said they hoped to file for FDA approval of their drug for mantle cell lymphoma this year. It's not clear when they'll file for market clearance of the treatment for patients with another cancer known as Waldenstrom's macroglobulinemia. The drug for use in these two cancers is in the middle stages of study historically needed for approval. Both cancers are rare types of non-Hodgkin lymphoma.

"This is a historic moment in oncology," Pharmacyclics CEO Robert Duggan says in a statement. "This compound entered the clinic in 2009 and has demonstrated tremendous clinical progress over the past four years."

Pharmacyclics plans to talk more about its drugs in development during a quarterly conference call scheduled for Thursday at 4:30 p.m. ET. Access the conference here.

Vertex Pharmaceuticals (VRTX) said last month that the FDA granted the breakthrough therapy tag to the company’s cystic fibrosis drug Kalydeco. The drug is approved for children with a certain genetic mutation but Vertex is studying the medicine for broader use. The FDA designated the drug twice as a breakthrough product for use as a single medicine and in combination with another experimental drug.

Shares of Vertex are up 27% over the past year, trading at $46.03 Wednesday morning.

The new breakthrough classification for experimental medicines was put into law as part of the 2012 Food and Drug Administration Safety and Innovation Act.   

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