FDA approves Subcutaneous Herceptin for her2+ Breast Cancer
 

Subcutaneous Herceptin OK'd for Breast Cancer
Study found 86% of patients preferred it to IV formulation



by Ian Ingram, Deputy Managing Editor, MedPage Today
February 28, 2019

WASHINGTON -- The FDA approved a subcutaneous version of trastuzumab (Herceptin) for treating HER2-positive breast cancer on Thursday.

Two randomized trials confirmed the safety and efficacy of the new formulation, which combines the anti-HER2 targeted agent with hyaluronidase, an endoglycosidase, and will be branded Herceptin Hylecta.

In the HannaH trial, 596 operable, HER2-positive breast cancer patients with locally advanced or inflammatory disease were randomized to 8 cycles of chemotherapy plus either subcutaneous or intravenous trastuzumab. Following surgery, they received another 10 cycles of their respective trastuzumab therapy.

The study met both primary endpoints, demonstrating that subcutaneous trastuzumab's pharmacokinetics and rates of pathological complete response (pCR) were noninferior to standard IV therapy. Rates of pCR were 45.4% in the subcutaneous arm compared with 40.7% in the IV arm (4.7% difference, 95% CI -4.0% to 13.4%).

Adverse events (AEs) between the two formulations were generally similar in this study, but serious AEs occurred with more frequency in the subcutaneous group (21.0% vs 12.0%), driven mostly by increased rates of infections and infestations (8.1% vs 4.4%).

A second study, SafeHER, was a prospective, multinational, open-label trial that confirmed the safety and tolerability of subcutaneous trastuzumab in 1,864 HER2-positive breast cancer patients treated every 3 weeks for 18 cycles.

The most common AEs (≥10%) were arthralgia, cough, diarrhea, edema, fatigue, flushing, headache, injection site reactions, myalgia, nausea, pain in the extremities, pyrexia, rash, and upper respiratory tract infections.

A third study, PrefHER, examined patient preference. In it, 240 patients were randomized to subcutaneous trastuzumab followed by the IV formulation, or vice versa. Following treatment, 86% stated that they preferred the subcutaneous version, 13% the IV version, and 1% had no preference. As the subcutaneous formulation takes about 2 to 5 minutes to administer, time savings was the most common reason for preference over the IV version, which can take from 30 to 90 minutes. Those preferring the IV version cited injection site reactions as their reason.

The recommended dose of the new treatment is 600 mg trastuzumab and 10,000 units hyaluronidase administered subcutaneously every 3 weeks.

Re: FDA approves Subcutaneous Herceptin for her2+ Breast Cancer
 

Thank you so much for this, Learned Lani!

I would like more information as to the exact procedure, cost and wide market date expectations. Can you post the company website or any other such info?

Again, thanks a million for keeping this site informed.

Re: FDA approves Subcutaneous Herceptin for her2+ Breast Cancer
 

Given subcutaneously by nurse. Average visit 5 minutes. No loading dose required. No modification of dose for body weight required. Given every 3 weeks. Not to be administered by patient themselves. Cost savings comes from less facility, nurse time.

Popular in rest of world.

Available in April, perhaps as soon as April 1. Whether insurance will reimburse /when as yet undetermined. Genentech urged providers to utilize their access
program in the interim

Re: FDA approves Subcutaneous Herceptin for her2+ Breast Cancer
 

Thank you. If I ever need Herceptin again, this is a great alternative since my port cath damaged the vein it was in for 9 years. (I now have a rather large stent in that damaged area.) A boon for many other who may not need a port.