Roche’s Herceptin, like other larger cancer drugs in its portfolio, is under biosimilar assault. But with a new, easy-to-use combo product, the Swiss drugmaker may be able to defend its star against the copycats.
Monday, the FDA greenlighted a fixed-dose combination of Herceptin and add-on product Perjeta, administered under the skin alongside intravenous chemo, for early and metastatic HER2-positive breast cancer patients.
The new product, called Phesgo, comes in a single-dose vial and can be given in a treatment center or at home. After an initial eight-minute loading dose, each treatment takes about five minutes to administer.
That’s a big improvement for both doctors and patients on the convenience side, compared with using the drugs’ separate IV formulations. A loading dose of the meds in their original form takes about 150 minutes, and infusions take between 60 and 150 minutes thereafter, Roche said.
It’s also an improvement both groups may be particularly interested in at a time when people—particularly the immunocompromised, including breast cancer patients—are trying to avoid the COVID-19 pandemic by staying out of treatment centers as much as possible.
"Phesgo offers a treatment administration that supports the needs and preferences of individual patients, and helps to meet the increasing demand across the healthcare system for faster and more flexible treatment options," Levi Garraway, M.D., Ph.D., chief medical officer and head of global product development for Roche’s Genentech, said in a statement.
Roche, for its part, is hoping to see the product catch on quickly. It’s already made its case for adding Perjeta to Herceptin and chemo, showing last year as part of the phase 3 Aphinity trial that doing so slashed patients’ risk of cancer recurrence or death by 24%. And data from another recent study, the phase 2 PHranceSCa trial, showed 85% of patients preferred Phesgo to standard IV treatment.
If Roche can convince doctors to pick up the new product, it’ll help the Basel-based drugmaker ward off biosimilar challengers, which recently entered in the U.S. In the first quarter, knockoffs to Herceptin—along with fellow cancer blockbusters Avastin and Rituxan—shaved $885 million off the company’s sales.
Luckily for Roche, though, its suite of newer meds is picking up the slack. Together, PD-L1 therapy Tecentriq, multiple sclerosis drug Ocrevus and hemophilia A hotshot Hemlibra generated an additional $1.7 billion in sales compared with 2019’s first-quarter haul.