Regulatory officials in Finland have approved an expanded indication for Eli Lilly's [LLY] Gemzar (gemcitabine) in combination with paclitaxel for advanced breast cancer. Further EU and, most importantly, US approval should follow soon, providing Gemzar with a large range of indications and blockbuster status by the end of 2003.
Gemzar was first approved in 1996 for the treatment of unresectable pancreatic cancer and rapidly became the gold standard because of its mild toxicity profile and marginal improvement in efficacy. Gemzar was later approved for the treatment of non-small cell lung cancer in combination with cisplatin or carboplatin, further boosting the drugs sales.
Gemzar has now gained approval in Finland for the treatment of unresectable, locally recurrent or metastatic breast cancer refractory to adjuvant or neoadjuvant chemotherapy when used in combination with paclitaxel. Patients should have received prior treatment with an anthracycline-containing regimen, such as doxorubicin or epirubicin, unless contraindicated.
EU and North American submissions are underway in the same indication and Gemzar is expected to receive marketing approval in these regions before the end of the year.
Because Gemzar has a good safety and toxicity profile, the drug is also used heavily off-label in indications such as bladder cancer and ovarian cancer. Datamonitor estimates that such off-label usage could be responsible for up to 30% of Gemzar sales.
The approval of Gemzar for the treatment of breast cancer is a key part of Eli Lilly's ongoing development strategy for the drug, which should achieve blockbuster status in 2003 following sales of $875 million in 2002.
Lilly's development program for Gemzar is certain to continue using approvals in new indications, in combination with aggressive marketing, to drive sales of the product. However, with patent expiry approaching in 2010, Lilly must begin assessing the reformulation potential of Gemzar now to gain the maximum from its Gemzar product group. In particular, an oral formulation of Gemzar, such as that produced for GSK/Pierre Fabre's Navelbine and Roche's 5-FU prodrug Xeloda, would benefit Gemzar. This could allow the drug to be administered on a daily basis to maintain drug levels in the body and, perhaps, increase efficacy at the same time.