The FDA has now approved it in combination with another medicine called Lazcluze (lazertinib) as a first-line treatment for a type of lung cancer called non-small-cell lung cancer (NSCLC) that has certain genetic changes (mutations) in the EGFR (epidermal growth factor receptor) gene.NSCLC accounts for most lung cancer cases, and many are driven by changes (mutations) in the EGFR gene, which controls how cells grow and divide.
Certain EGFR mutations, such as exon 19 deletions, exon 21 L858R substitutions, and exon 20 insertions, promote growth and resistance to therapy in cancer cells, which makes them harder to treat.
These mutations are commonly seen in people with lung adenocarcinoma, which starts in mucus-producing lung cells; younger people who are nonsmokers; and Asian patients.
Although EGFR-targeted treatments can slow down the disease, long-term survival remains low, with fewer than 20% of patients surviving after five years, particularly those with exon 20 insertion mutations.
Rybrevant Faspro is injected under the skin and takes about five minutes to give. It combines two ingredients: amivantamab and hyaluronidase. Amivantamab is a first-in-class fully-human lab-made antibody that selectively targets cancer cells with EGFR and mesenchymal–epithelial transition (MET) gene mutations, blocking cancer cell growth signals and helping your immune system to identify and kill tumor cells. Hyaluronidase helps improve absorption of the medicine when it is injected under the skin.The treatment also includes Lazcluze, an oral targeted cancer medicine that blocks faulty EGFR signals and helps slow or stop the spread of cancer cells. This approval matters, as Rybrevant Faspro is the first and only subcutaneous treatment approved for EGFR-mutated NSCLC that provides a quicker and less invasive treatment that may reduce the time you spend at the clinic and make it easier for you to follow your treatment plan. It also offers a chemotherapy-free frontline option for people with advanced or spreading lung cancer. Rybrevant Faspro is approved for the same uses as Rybrevant and can be used in EGFR-positive NSCLC as a first treatment or after other treatments stop working, either with Lazcluze, with chemotherapy, or alone, depending on the EGFR mutation and prior therapy.
Why Was It Approved?
The FDA approval of Rybrevant Faspro was based on clinical studies showing it was safe and equally effective as its IV version for treating EGFR-mutated NSCLC when combined with Lazcluze, with fewer administration-related reactions and improved overall survival. In a study of 418 patients with EGFR-mutated advanced NSCLC whose disease got worse after osimertinib and platinum-based chemotherapy, 206 received SC Rybrevant Faspro and 212 received IV Rybrevant, both combined with Lazcluze. Results showed thatSC Rybrevant Faspro achieved similar blood medicine levels as the IV form. Response rates were comparable, with 30% and 33% of patients benefitting from the SC and IV forms, respectively. But patients went longer without their cancer worsening with the SC versus IV form (6.1 versus 4.3 months), and overall survival improved. After a year, more patients on the SC form were alive, compared with those treated with the IV form (65% versus 51%). Fewer patients on Rybrevant Faspro had infusion reactions (13% versus 66%) or blood clots (9% versus 14%) than those on IV Rybrevant. Rybrevant Faspro can be given more quickly (median administration time, 4.8 minutes, versus 5 hours with IV), and more patients considered it to be very convenient or convenient (85% versus 52% at first dose, and 85% versus 35% at the end of treatment), compared with those on IV Rybrevant.
What Do I Need to Know?
Rybrevant Faspro is given by a health care provider as an injection under the skin, usually in the belly, and takes about five minutes to administer. At first, you’ll get it once a week. And later, it may be given every two weeks. Your health care provider will decide your dosing schedule depending on your weight and treatment plan. If you miss an appointment, contact your health care provider right away to reschedule.
