Johnson & Johnson (JNJ) announced FDA approval for the subcutaneous formulation of its EGFR/MET inhibitor, Rybrevant (amivantamab), now known as Rybrevant Faspro. This approval allows the drug to be used across all indications already covered by its intravenous version, which treats patients with EGFR-mutated non-small cell lung cancer (NSCLC).
The new SC formulation offers significant advantages, allowing administration in as little as five minutes compared to the several hours required for the IV version. The approval was supported by data from the late-stage PALOMA-3 study, confirming that Rybrevant Faspro is at least as effective as its IV counterpart. Following a rejection of an earlier filing due to manufacturing concerns, this approval places J&J in a better competitive position against AstraZeneca’s Tagrisso, the current market standard for NSCLC treatment.
J&J’s oncology sales have surged nearly 21% year-over-year, totaling $18.52 billion in the first nine months of the year, with ambitious plans to reach $50 billion in oncology sales by the end of this decade. The company is also expanding its oncology pipeline, recently announcing a $3.05 billion acquisition of Halda Therapeutics.
