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Health Canada Drug Approvals | Healthcare and Pharmaceutical News of Canada | News | Blogs | Canada

Updated: Jun 26

Health Canada approved Rybrevant for EGFR exon insertion mutation NSCLC.

Janssen announced that Health Canada issued a Notice of Compliance with Conditions (NOC/c) to approve Rybrevant (amivantamab) for treating patients with EGFR exon 20 insertion mutation non-small cell lung cancer disease has progressed after platinum-based chemotherapy.

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NOC/c was issued based on the CHRYSALIS study, in which the efficacy was demonstrated in patients whose cancer progressed after platinum-based chemotherapy. The efficacy was observed based on the overall response rate (ORR) and duration of response (DOR).

Janssen announced that Rybrevant targets both cancer-driving and resistant mechanisms. The drug previously received approval from the US FDA in May 2021.

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Johnson and Johnson has announced that it has received the approval of Cabenuva

The Janssen Pharmaceutical Companies of Johnson and Johnson has announced that it has received the approval of Cabenuva (cabotegravir and rilpivirine extended release injectable suspensions) by Health Canada. Cabenuva is the first and only once-monthly, long-acting regimen for the treatment of HIV-1 infection in adults.

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Cabenuva has two injections, one is Janssen's rilpivirine and the other is ViiV Healthcare's cabotegravir.

"At Johnson & Johnson, we are dedicated to changing the course of the HIV epidemic through our pursuit of improved therapies and the development of an HIV vaccine," said Paul Stoffels, M.D., Vice Chairman of the Executive Committee and Chief Scientific Officer of Johnson & Johnson.

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The approval is based on ATLAS and FLAIR studies.

ATLAS study was a Phase 3, open-label active controlled study. The study designed to prove the non-inferiority of Cabenuva compared to two nucleoside reverse transcriptase inhibitors (NRTIs) plus an integrase strand transfer inhibitor (INSTI), non-nucleoside reverse transcriptase inhibitor (NNRTI), or protease inhibitor (PI).

FLAIR is a Phase 3, open-label, active controlled study. The study included adult patients with HIV who are virologically suppressed (patients who were inducted with induction therapy with either dolutegravir/abacavir/lamivudine or dolutegravir plus 2 other NRTIs).  

The company claimed that nine out of ten patients preferred Cabenuva compared to the oral daily treatment.

Trademark is owned by ViiV and Janssen. ViiV Healthcare holds the market authorization of Cabenuva in Canada. The drug is developed in collaboration between Janssen and ViiV.

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