Halozyme Therapeutics, Inc. HALO announced today that Roche received a positive recommendation from the
European Medicines Agency's Committee for Medicinal Products for Human Use
(CHMP) for the subcutaneous formulation of Herceptin^® (trastuzumab) using
Halozyme's recombinant human hyaluronidase (rHuPH20) for the treatment of
patients with HER2-positive breast cancer in Europe.
Roche's pivotal Phase 3 HannaH study, conducted in 102 sites outside the US,
demonstrated that Herceptin SC may help decrease the time patients spend
receiving treatment at a hospital or physician's practice, by reducing the
administration time. A typical IV infusion of Herceptin can take 30 to 90
minutes, per dose, whereas the same dose delivered subcutaneously can be
administered in two to five minutes by an injection under the skin.^1
"Pending European approval, this subcutaneous formulation of Herceptin will
provide a new route of administration that could potentially save time for
both physicians and HER2-positive breast cancer patients in Europe," said
Gregory I. Frost, Ph.D., President and Chief Executive Officer, Halozyme
Therapeutics. "We are pleased that our technology has helped enable this new
option for patients."
Study results showed that the safety and efficacy of the subcutaneous
formulation of Herceptin is comparable to treatment with Herceptin
administered intravenously.^1 Overall, the safety profile in both arms of the
HannaH study was consistent with that expected from standard treatment with
Herceptin and chemotherapy in this setting. No new safety signals were
identified.
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