FDA approves combination Herceptin and Perjeta for HER2-positive breast cancer

The Food and Drug Administration approved pertuzumab, trastuzumab, and hyaluronidase-zzxf (Phesgo), a new combination medicine, for treatment of early-stage and metastatic breast cancers. The treatment combines the HER2-targeted therapies trastuzumab (Herceptin) and pertuzumab (Perjeta) with a protein that allows it to be given as an injection. The news was announced in June 2020 by Genentech, the maker of Herceptin, Perjeta, and Phesgo.

Giving these medicines by injection takes less than 10 minutes where the previous method, infusion, typically takes 1 to 2 hours.

Background

Trastuzumab and pertuzumab are a common combination for the treatment of HER2-positive breast cancer.

Typically they are given by infusion, a method that involves dripping the medicine through a needle into a vein or through a port over the course of 1 to 2 hours. The dose for an infusion is based on your weight.

The protein hyaluronidase has been found to help the body absorb trastuzumab, allowing it to be given as an injection under the skin rather than infused directly into a vein. The combination, trastuzumab and hyaluronidase-oyst (Herceptin Hylecta) was approved by the FDA as an injectable form of trastuzumab in early 2019.

An injection can be given in a fraction of the time it takes to give an infusion. The combination of trastuzumab and pertuzumab takes at least an hour and can last 150 minutes. The pertuzumab, trastuzumab, and hyaluronidase-zzxf injection does not need to go in a vein and can be done in less than 10 minutes. The injection has a fixed dose, which means the amount of medicine does not have to be calculated based on your weight.

Approval

The FDA approval was based primarily on the phase III FeDeriCa study, which looked at the levels of pertuzumab and trastuzumab in the blood. They were randomized to two arms

• Arm A received trastuzumab and pertuzumab by vein
• Arm B received pertuzumab, trastuzumab, and hyaluronidase-zzxf injections

All participants were treated before surgery with 8 cycles of chemotherapy along with the treatment they were assigned. After surgery they continued on their assigned treatments.

The FeDeriCa study met the goals for non-inferiority, showing that getting the treatments by injection was not less effective than getting it by infusion. The study proved this by showing that the amount of medicine in the bloodstream of people given pertuzumab, trastuzumab, and hyaluronidase-zzxf injections was similar to the amount seen in patients getting pertuzumab and trastuzumab by infusion.

The side effects of the two methods were similar as well, with the most common being hair loss, nausea, diarrhea, and low red blood cell counts. Like pertuzumab and trastuzumab given separately, pertuzumab, trastuzumab, and hyaluronidase-zzxf injections come with a risk of serious heart problems. Your doctor should regularly check for complications.

Separately, the phase II PHranceSCa study looked at people’s preference for treatment. Participants were given 3 weeks of pertuzumab, trastuzumab, and hyaluronidase-zzxf injections and 3 weeks of pertuzumab and trastuzumab infusion by vein, then chose the method they wanted to use for the remainder of their treatment. The study found 82 percent of people who completed both methods of treatment preferred the combined shot over the infusion. More people also reported being “very satisfied” or “satisfied” with the combined injection compared to the traditional infusion:

• 90 percent said they were satisfied or very satisfied with pertuzumab, trastuzumab, and hyaluronidase-zzxf injection
• 67 percent said they were satisfied or very satisfied getting pertuzumab and trastuzumab by infusion

What this means for you

The availability of pertuzumab and trastuzumab as an injection is an important option for treatment. The injection takes less time than an infusion and requires less time in the cancer center and can even be given by a healthcare professional in your home. The PHranceSCa study showed a clear preference for treatment with injection. Especially now, the prospect of spending less time at a cancer center may be a welcome option as COVID-19 remains a concern in public, indoor spaces.

It is possible to switch to injection even if you are currently getting trastuzumab and pertuzumab by infusion. If you are interested, you should speak to your doctor about your options. Genentech, the maker of the combined injection, says the price for injection is lower than the infusion even with a biosimilar of trastuzumab, but you should also contact your insurance provider about paying for injection treatment. Genentech has assistance programs to help people who are uninsured or underinsured access their treatments.