FDA approves Herceptin Hylecta for subcutaneous injection in certain HER2-positive breast cancers - Seite 2

The most common side effects in people receiving Herceptin Hylecta for early breast cancer were feeling tired, joint pain, diarrhoea, injection site reaction, upper respiratory tract infection, rash, muscle pain, nausea, headache, swelling, flushing, fever, cough, and pain in extremity.¹


HannaH, SafeHER and PrefHER study results¹

HannaH
	Herceptin Hylecta	Intravenous Herceptin
pCR (absence of invasive cancer cells in the breast)	45.4% (118/260) 95% CI 39.2%-51.7%	40.7% (107/263) 95% CI 34.7%-46.9%
Mean level of trastuzumab in the blood (Ctrough) before dosing eighth cycle	78.7 mcg/mL	57.8 mcg/mL
	Geometric mean ratio 1.3 (90% CI 1.2-1.4)
Most common adverse events (AEs; >=10%)	Hair loss, nausea, administration-related reactions, feeling tired, decreased neutrophil count, diarrhoea, rash, upper respiratory tract infection, vomiting, mouth blisters or sores, muscle pain, decreased appetite, constipation, radiation skin injury, damage to the nerves (numbness, tingling, pain in the hands/feet), joint pain, flushing, fever, cough, low levels of red blood cells, difficulty breathing, incision site pain, low levels of white blood cells and mucosal inflammation
SafeHER
	Herceptin Hylecta n=1,864
Safety	No new safety signals for Herceptin Hylecta were identified. Safety and tolerability were consistent with the known safety profiles of intravenous Herceptin and Herceptin Hylecta
Most common AEs (>=10%)	Administration-related reactions, feeling tired, diarrhoea, injection site reaction,weakness, joint pain. rash, muscle pain, nausea, damage to the nerves (numbness, tingling, pain in the hands/feet), headache, swelling, flushing, fever, cough, and pain in extremity
PrefHER
	Herceptin Hylecta followed by intravenous Herceptin (n=121) or intravenous Herceptin followed by Herceptin Hylecta (n=119)
Patient preference	86% of people preferred Herceptin Hylecta, 13% preferred intravenous Herceptin, 1% had no preference
Reasons for preference	The most common reason for preferring Herceptin Hylecta was time savings (179/231). The most common reason for preferring intravenous Herceptin was fewer local injection reactions

About Herceptin Hylecta