The US FDA has also approved Guardant Health's Guardant360 CDx liquid biopsy blood test as a companion diagnostic for use with Rybrevant
Janssen Pharmaceutical Companies of Johnson & Johnson. (Credit: Vysotsky/Wikipedia.)
Johnson & Johnson’s pharmaceutical business Janssen has received the US Food and Drug Administration (FDA) accelerated approval for Rybrevant (amivantamab-vmjw) to treat adult patients with a type of lung cancer.
Rybrevant is indicated for epidermal growth factor receptor (EGFR) mutation-positive metastatic non-small cell lung cancer (NSCLC) in patients whose disease has progressed on or after platinum-based chemotherapy.
Simultaneously, the US regulator has approved Guardant Health’s Guardant360 CDx liquid biopsy blood test as a companion diagnostic for use with Rybrevant.
The next-generation sequencing test is designed to provide an alternative to a polymerase chain reaction (PCR)-based tests which fail to identify 50% or more of exon 20 insertion mutations, said the company.
Janssen research and development global oncology therapeutic area head Peter Lebowitz said: “The approval of Rybrevant, along with the companion diagnostic test, addresses high unmet need in the treatment of people with genetically defined non-small cell lung cancer.
“At Janssen, we are committed to the development of innovative therapies like RYBREVANT and believe that advancing medicines targeting specific pathways can bring the greatest benefits and improve outcomes for patients with tumour alterations such as EGFR and MET.”
Rybrevant is said to be the first fully human, bispecific antibody approved for the treatment of patients with NSCLC that targets EGFR exon 20 insertion mutations.
The US FDA has granted Breakthrough Therapy Designation (BTD) for the drug in March 2020, and Priority Review of the Biologics License Application (BLA) in December 2020.
The accelerated FDA approval is based on positive results from the Phase 1 CHRYSALIS study, which evaluated the safety, pharmacokinetics and preliminary efficacy of the drug as both monotherapy and in combinations.
The study evaluated Rybrevant as a monotherapy, in patients with locally advanced or metastatic NSCLC with EGFR Exon 20 insertion mutations weighing less than 80kg.
Disease response using the overall response rate (ORR), as evaluated by Blinded Independent Central Review (BICR), was the primary endpoint.
Adverse events of the treatment include pneumonia, infusion-related reactions (IRR), pneumonitis/interstitial lung disease (ILD) dyspnea, pleural effusion and rash.
Janssen research and development, and Johnson & Johnson global head Mathai Mammen said: “Today’s milestone reflects progress and determination in our mission to develop and deliver transformational therapies to improve the lives of people diagnosed with some of the most devastating and complex diseases of our time.
“The approval of Rybrevant, the first lung cancer treatment for Johnson & Johnson, strengthens our commitment to harness science, expertise and scale to dramatically alter the trajectory of lung cancer, and reduce the impact of the world’s leading cause of cancer mortality.”