There are a number of interesting cancer drugs in development that may receive approval this year.  Many of them are from biotech rather than pharma and focused on niche indications.

First up is Genzyme's Clolar (clofarabine), which was filed as a supplemental application in the US on November 24th with a request for priority approval in adult acute myeloid leukemia (AML).  Clolar is already approved for use in relapsed and refractory ALL in both the US and EU.  Data in elderly AML was also presented at the recent American Society of Hematology (ASH) meeting, with unprecedented response rates in a notoriously hard to treat group with a poor prognosis.  No doubt that data will be used to support the initial filing in the over 60 yo patients.

Another exciting compound is pralatrexate from Allos Therapeutics, which is being investigated in peripheral T-cell lymphoma (PTCL), a form of Non-Hodgkins Lymphoma (NHL).  It is also being tested in other cancers including cutaneous T-cell lymphoma (CTCL), NHL, non-small cell lung cancer (NSCLC) and transitory clear cell carcinomas of the bladder.  Pralatrexate has received orphan drug designation and
fast track designation in the U.S. for the treatment
of patients with T-cell lymphoma and orphan medicinal product designation in Europe
for the treatment of PTCL. There are currently no FDA-approved agents
for patients with PTCL, either in the
first-line or relapsed or refractory
setting. Filing is expected in the first half of 2009 in the US, with possible approval within six months, if
successful.

Both PTCL and CTCL are relatively uncommon and yet several companies are fighting a tight battle to gain early entrance to the markets and also for efficacy data.  Another drug being developed in this area is romidepsin from Gloucester Pharmaceuticals.  Post ASH, it looks as if Allos may have the advantage in PTCL and Gloucester in CTCL.  The two drugs have very different mechanisms of actions, which makes it more interesting.  Romidepsin is an HDAC inhibitor, while pralatrexate is an anti-folate compound.

Novartis' Afinitor (everlimus, RAD001) has already been submitted to the FDA for approval in renal cell cancer.  The initial indication is expected to be in patients who have failed Pfizer's Sutent or Bayer's Nexavar, but may well turn out to be the treatment of choice given the proof of concept shown by another mTor inhibitor in that cancer, Torisel from Wyeth.  Incidently, if the Wy-Pfi merger goes ahead, the company may be forced to choose from either Sutent or Torisel, given the overlap in the cancer type.

Last November, Ortho Biotech submitted a BLA for trabectedin when administered in combination with Doxil (doxorubicin
HCl liposome injection) for the treatment of women with relapsed
ovarian cancer (ROC). If approved, trabectedin combined with Doxil will
provide a new, non-platinum treatment option for these patients in the
United States.

Meanwhile, GSK are seeking an NDA for their PDGF inhibitor, pazopanib in for renal cell cancer in the US and EU, and a BLA in both the US and Europe for Arzerra (ofatumumab), a CD20 monoclonal antibody in co-development with Genmab for relapsed, refractory CLL. 

December was a busy month for submissions as Amgen also submitted a BLA denosumab, an investigational RANK Ligand inhibitor. The indications
for which Amgen is seeking FDA approval are treatment and prevention of
postmenopausal osteoporosis (PMO) in women, and treatment and
prevention of bone loss in patients undergoing hormone ablation for
either prostate or breast cancer. The BLA submission contained data from
six Phase 3 trials involving more than 11,000 patients.

All in all, many of these agents may receive fast track or priority designation from the FDA, so we may well see several new cancer drugs on the market for a wide range of tumours by the year end.  It's a fascinating time in the oncology arena and there may be other cancer drugs that I've missed.  If so, please add them in the comments so we can track them.