FDA Oncology Announcements

Anti-EGFR-HGFR bispecific × Clear all

5 Announcements

FDA approves amivantamab and hyaluronidase-lpuj for subcutaneous injection

Trial: PALOMA-3
Drug: Rybrevant Faspro (amivantamab and hyaluronidase-lpuj) · Anti-EGFR-HGFR bispecific antibody
Condition: Thoracic

FDA approves amivantamab-vmjw with carboplatin and pemetrexed for non-small cell lung cancer with EGFR exon 19 deletions or L858R mutations

Trial: MARIPOSA-2
Drugs: Rybrevant (amivantamab-vmjw) · Anti-EGFR-HGFR bispecific antibody, carboplatin · Platinum agent, pemetrexed · Antifolate
Condition: Thoracic

FDA approves lazertinib with amivantamab-vmjw for non-small lung cancer

Trial: MARIPOSA
Drugs: Lazcluze (lazertinib) · EGFR inhibitor, Rybrevant (amivantamab-vmjw) · Anti-EGFR-HGFR bispecific antibody
Condition: Thoracic

FDA approves amivantamab-vmjw for EGFR exon 20 insertion-mutated non-small cell lung cancer indications

Trial: PAPILLON
Drugs: Rybrevant (amivantamab-vmjw) · Anti-EGFR-HGFR bispecific antibody, carboplatin · Platinum agent, pemetrexed · Antifolate
Condition: Thoracic

FDA grants accelerated approval to amivantamab-vmjw for metastatic non-small cell lung cancer

Trial: CHRYSALIS
Drug: Rybrevant (amivantamab-vmjw) · Anti-EGFR-HGFR bispecific antibody
Condition: Thoracic