Johnson & Johnson has received coal in its stocking from the FDA as manufacturing issues have tripped up the company’s attempt to gain approval of its subcutaneous version of lung cancer drug Rybrevant (amivantamab).
The U.S. regulator sent J&J a complete response letter (CRL) rejecting its application to clear Rybrevant’s injected formulation for patients with non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) mutations.
The FDA also has sent a CRL to AstraZeneca, swatting its request for full approval of Andexxa, which reverses the anticoagulant effect of blood thinners. The thumbs down was not a surprise as it came three weeks after an FDA advisory panel questioned Andexxa’s safety profile.
The rejection for J&J was based on observations FDA officials made at a manufacturing facility during a standard pre-approval inspection. The CRL is not related to the formulation of the treatment or its efficacy or safety, the company explained in a release. The agency has not asked J&J to conduct an additional clinical study and its current approval for Rybrevant’s intravenous remains unaffected, the drugmaker added.
“We’re working closely with the FDA to bring SC amivantamab to patients as quickly as possible, and are confident in our path to resolution,” Yusri Elsayed, M.D., Ph.D., J&J’s global therapeutic area head for oncology, said in a release.
There has been much anticipation for Rybrevant’s injected version since the company reported seven months ago that it had performed better than intravenous Rybrevant in a clinical trial, reducing the risk of death by 38%.
In August, the FDA approved Rybrevant and Lazcluse as a first-line treatment for NSCLC with EFGR mutations. A win for SC Rybrevant could help J&J in its challenge against AZ’s EGFR standout Tagrisso, which is an oral drug. While IV Rybrevant can take up to five hours to administer, the SC version only takes up to seven minutes or five minutes at median.
As for the FDA's rejection of Andexxa, the company said in an email that it will keep the treatment on the market in the U.S. AZ confirmed the CRL, which was reported last week by Pink Sheet.
In the first nine months of this year, Andexxa generated U.S. sales of $61 million and $159 million worldwide, which was up 24% year over year. It has been on the market since 2018 when Portola Pharmaceuticals scored its accelerated approval.
In 2020, Alexion bought out Portola in a much-criticized $1.4 billion deal. A year later, AZ acquired Alexion.