Janssen EMEA gets conditional marketing authorisation for Rybrevant in NSCLC patients

Janssen (NYSE:JNJ) has received European authorisation for Rybrevant (amivantamab-vmjw) to treat adults with non-small cell lung cancer (NSCL) with activating epidermal growth factor receptor (EGFR) exon 20 insertion mutations.

Rybrevant is a fully-human EGFR-MET bispecific antibody.

NSCL is responsible for the majority of lung cancers.

The Conditional Marketing Authorisation (CMA) covers patients who have failed platinum-based chemotherapy.

Amivantamab is the first treatment to win approval in the EU specific to EGFR exon 20 insertion mutations for NSCLC. “Patients with NSCLC harboring EGFR exon 20 insertion mutations represent a specific population who have been underserved by current treatment options that are limited in both number and efficacy,” said Dr. Antonio Passaro, Medical Oncologist at the Division of Thoracic Oncology of the European Institute of Oncology, in a press release.

Clinical trials for amivantamab are underway for sol…

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Lilly wins Erbitux label expansion for colorectal cancer indication

FDA has approved a new indication for Lilly‘s (NYSE:LLY) Erbitux (cetuximab injection) in combination with Pfizer’s Braftovi (encorafenib) to treat adults with metastatic colorectal cancer (CRC) with a BRAF V600E mutation confirmed with an FDA-approved test.

The indication covers previously-treated patients.

Erbitux is currently the only FDA-approved antibody that targets the epidermal growth factor receptor (EGFR). Merck (NYSE:MRK) was also involved in developing the drug.

The recent label expansion is based on data from Pfizer’s Phase 3 BEACON CRC study, which focused on patients with metastatic colorectal cancer with a BRAF V600E mutation.

The latest approval gives Erbitux a total of seven indications covering various colorectal and head-and-neck cancers.

“The BEACON study showed that the combination of ERBITUX and encorafenib significantly improved overall survival in patients with metastatic colorectal cancer with a BRAF V600E mu…

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