The world’s second-biggest drugmaker, GlaxoSmithKline PLC
said Friday that the European Medicines Agency (EMEA) has given a favorable
vote on the company’s breast cancer drug Tyverb and received a conditional
marketing approval.
The drug, also known as lapatinib, is a small molecule,
which combined with capecitabine, is recommended for patients who have advanced
breast cancer or breast cancer that has spread to other parts of the body,
especially brain.
Lapatinib is the first oral drug that works by entering the
cancer cell to inhibit both ErbB1 and ErbB2, the two receptor proteins that are
responsible for tumor growth.
The ruling was received as good news for thousands of women
in Europe diagnosed each year with aggressive breast
cancer, said Martine Piccart, professor of oncology at the Universite Libre de
Bruxelles.
"Lapatinib represents an important new treatment option for a group of
patients in real need of alternative therapies, and I look forward to the day
that I can prescribe lapatinib," she said, according to the Houston
Chronicle.
The news is a boost for Glaxo, which is aiming to increase
its position in the fast-growing cancer market. The conditional approval – if endorsed
by the European commission within a couple of months, as expected – means the
drug can sold immediately but that additional clinical data are still required.
The medicine is already on sale in the United States,
but with a slightly modified name, Tykerb. In a brain cancer trial, Tykerb,
used with Roche Holding AG’s drug Xeloda, shrank the size of tumors by at least
20 percent in 18 of 47 women participating at the trial. Moreover, 10 of those
18 patients had brain tumors reduced to half the original size, the researchers
at the college’s Breast Care Cancer said in a December 14 telephone interview.
“This is the first small proof we're going in the right direction. In the
future, we may figure out ways to block the stem cells and eradicate breast cancer,”
Jenny Chang, the lead researcher and medical director at the college’s BCC
said.
Administered as a pill, Tykerb seems to be more convenient
than Roche and Genentech Inc’s Blockbuster Herceptin, which works in similar
way but must be injected.
The finding is significant because about one third of women
with advanced breast cancer who carry the HER-2 gene develop tumors in the
central nervous system, including the brain. Chemotherapy, radiation or surgery
numbers among the current treatment for tumors that spread to the brain.