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Monday, Dec 4, 2023

FDA Panel Recommends Approval of Cancer Treatment

Biotech: Drug Has Potential for Patients In Advanced Stages

A Food and Drug Administration advisory committee is recommending approval of Ligand Pharmaceuticals Inc.’s experimental cancer drug Targretin for patients with advanced-stage cutaneous T-cell lymphoma.

Ligand announced Dec. 13 the oncologic drug advisory committee voted 13-2, with one abstention, to recommend approval for Targretin for cutaneous T-cell lymphoma.

However, the panel voted 7-5, with four abstentions, against recommending Targretin for patients with early-stage cutaneous T-cell lymphoma, requesting more data on long-term risks.

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“We are pleased with the panel’s vote to recommend Targretin capsules approval for advanced-stage CTCL patients, but disappointed that Targretin capsules was not also recommended at this time for the early-stage CTCL patient population,” said David E. Robinson, Ligand’s chairman, president and chief executive.

If the Targretin capsule is approved by the FDA, it will be the first oral retinoid on the market for the treatment of patients with cutaneous T-cell lymphoma, a cancer in which patients develop patches on their skin that itch and become inflamed, Ligand said.

The FDA generally follows the advice of the advisory committee and under an expedited review is expected to make its decision on Targretin by the end of December.

Some panel members and FDA officials criticized Ligand for not designing its studies to include a control group, which helps them to better determine benefits of the drug, according to Bloomberg News.

The panel also recommended Ligand continue studies of Targretin if it is approved, because participants in the study had to take other medications to treat side effects, such as high cholesterol, hypothyroidism and headaches.

Ligand had hoped Targretin would have a potential use for other cancers, such as breast cancer, where the market is bigger, said Stefan Loren, an analyst at Legg Mason.

But the various side effects have put a damper on Ligand’s optimism, Loren said, adding the decision is a setback for the company.

“Ligand needs at least $100 million in revenue to break even. Had they been there with flying colors, they might have been able to get $10 million to $20 million from both (early and late stage) indications,” Loren said in a published report.

Ligand shares were halted before the panel meeting.

On Dec. 14, Ligand shares fell a half-cent to $11.19.

If Targretin is approved, Ligand would have three drugs on the market. In February, the FDA approved Ligand’s lymphoma drug Ontak and its AIDS-related Kaposi’s sarcoma drug Panretin.


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