The US Food
and Drug Administration's (FDA) Oncologic Drugs Advisory Committee (ODAC) today
unanimously voted to recommend the approval of biosimilar versions of two of Genentech’s
top selling cancer drugs, Avastin (bevacizumab) and Herceptin (trastuzumab).
Herceptin®, is
used in treatment of HER2-positive breast cancer in the metastatic and adjuvant
settings while Avastin is used in colorectal, ovarian, cervical, brain and
renal cell cancers.
In the
morning session, the ODAC members voted 17-0 in favor of approving Amgen's
Avastin biosimilar ABP 215, for six of 8 originally approved indications for Avastin,
as they are covered by orphan drug exclusivity until 2021 and 2023.
In the
afternoon session, ODAC members voted 16-0 in favor of approving Mylan's
Herceptin biosimilar candidate, MYL-1401O, for all of Herceptin's indications,
including an indication for metastatic gastric cancer, which is protected by
orphan drug exclusivity through 20 October 2017.
For both the
drugs the FDA and committee members felt that there were no clinically
meaningful differences between the reference products and the biosimilars. However,
some members were worried about extrapolating the data from studies pertaining
to single disease to multiple indications in actual clinical application.
Courtney J.
Preusse, MA, ODAC's consumer representative and a research administrator at
Fred Hutchinson Cancer Research Center in Seattle said, “I would like to
strongly applaud the sponsor for equivalence results that were very solid and
for what appears to be the first proposal for a biosimilar for a drug that's
been on the market for almost three decades.”
To gain the
approval, Mylan has submitted clinical trial data comparing MYL-14010 and European
Union trastuzumab. The trial recruited 458 patients with untreated metastatic
breast cancer, who were randomized to receive MYL-14010 or EU-trastuzumab in
combination with a taxane, for a minimum of eight cycles.
Those
patients whose disease was stabilized were put on single agent MYL-14010 or
EU-trastuzumab for a period until the disease progressed or drug toxicity
developed.
In an
intention to treat analysis, overall similar response was achieved with both
the drugs. No difference was observed in safety analysis also.
The FDA and ODAC
report concluded that the clinical trials have
shown "that there are no clinically meaningful differences between
MYL-14010 and US-Herceptin in terms of the safety, purity, and potency of the
product."
Photo courtesy: Genentech
