FDA Approves Handa’s Improved Cabometyx Drug; Analysts See Limited Threat to Existing Drug

The U.S. Food and Drug Administration (FDA) has granted final approval to a new drug from Handa Pharmaceuticals that improves on Exelixis’ cancer drug Cabometyx. However, analysts say the threat to the existing drug is limited.

Handa Pharmaceuticals, which is headquartered in the United States and Taiwan, announced the previous day that it had received final FDA approval for Omcazio capsules, Fierce Pharma reported on the 12th (local time).

Omcazio is an improved drug that uses cabozantinib, the tyrosine kinase inhibitor in Exelixis’ Cabometyx, in lauryl sulfate salt form. It was developed by Handa Oncology, a Handa subsidiary, and the approval allows it to be sold in the United States.

This is the third time Handa’s branded drug improvement strategy has borne fruit. Handa is already marketing in the United States Pifaygo, an improved version of Bristol Myers Squibb’s (BMS) cancer drug Sprycel, and Tasenso ODT, an improved version of Novartis’ multiple sclerosis treatment Gilenya.

Omcazio’s key advantage is that it can be taken regardless of food intake. In a statement, Handa CEO Bill Liu said it offers doctors and patients “additional flexibility in treatment.”

The drug can be used in adults with advanced renal cell carcinoma as a first-line treatment in combination with BMS’ Opdivo, and in patients with hepatocellular carcinoma treated with Bayer’s Nexavar, among other uses.

Handa said Cabometyx’s once-daily doses of 60, 40 and 20 mg correspond to Omcazio doses of 34.5, 23 and 11.5 mg, respectively. Cabometyx generated $2.11 billion in U.S. sales last year, a 17% increase.

William Blair analysts said in a client note that day that they did not view Omcazio’s final approval as a threat. Pointing to the gap between approval and actual sales, they said Handa’s drug “is not equivalent to Cabometyx.”

Omcazio was approved through the FDA’s 505(b)(2) pathway based on bioavailability and bioequivalence data. The pathway is often used to develop improved drugs because it allows some data from previously approved drugs to be used.

Omcazio’s label states that it cannot be substituted on a milligram-for-milligram basis for other cabozantinib products. William Blair therefore said Handa would “likely need to build a sales force” and forecast that Omcazio’s adoption in the United States would be “minimal.”