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Commentary on Pharma & Biotech Oncology / Hematology New Product Development

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Pfizer’s Crizotinib (Xalkori) approved in ALK-positive lung cancer!

The FDA just announced that they have approved Pfizer’s crizotinib (Xalkori):

The U.S. Food and Drug Administration today approved Xalkori (crizotinib) to treat certain patients with late-stage (locally advanced or metastatic), non-small cell lung cancers (NSCLC) who express the abnormal anaplastic lymphoma kinase (ALK) gene.

Xalkori is being approved with a companion diagnostic test that will help determine if a patient has the abnormal ALK gene, a first-of-a-kind genetic test called the Vysis ALK Break Apart FISH Probe Kit. It is the second such targeted therapy approved by the FDA this year.


Abiraterone (Zytiga)This afternoon the FDA approved Ortho Biotech’s abiraterone acetate (Zytiga) in combination with prednisone for the treatment of castrate resistant prostate cancer in patients who have received prior chemotherapy with docetaxel.

Abiraterone was filed on December 20th, 2010 and received fast track designation, so the FDA approval comes 2 months ahead of the expected PDUFA date of June 20th.

It represents another exciting advance for this disease after what Dr Bernard Tombal described as a “Grand Cru” year for prostate cancer in 2010 following the successive launches of cabazitaxel (Jevtana), sipuleucel-T (Provenge) and denosumab (Xgeva), the first since docetaxel (Taxotere) was approved back in 2006 for chemotherapy naive metastatic disease.


Amgen’s recent announcement of phase III trial data showing that it’s monoclonal antibody, denosumab was superior to Novartis’ Zometa (zoledronic acid) for the treatment of breast cancer patients with bone mestastases is further news that scientifically driven drug development can yield exciting results.

Denosumab is in essence a targeted therapy like Gleevec, Avastin or Herceptin.  It’s development came about from basic research that discovered the cellular control of bone remodelling and regulation of bone density is reglated by the RANK Ligand pathway.

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