Ziihera’s Clinical Trial Results

A⁣ clinical trial conducted by the drugmaker revealed that 62 patients with cholangiocarcinoma, a​ type of bile duct cancer, received Ziihera. The trial specifically ⁤excluded patients who had previously been treated with a HER2-targeted drug for their cancer, as‌ detailed in the trial documentation.

‍ Over half of the participants (52%) demonstrated a positive response to Ziihera, with the effects lasting a median ⁤of 15 months.Dr. Nipun Merchant, chief of surgical oncology at the University of ⁢Miami Health System’s Sylvester Extensive Cancer ​center, ⁢noted that a response rate “More than 50% is amazing for second-line therapy,” adding that ‌such results are uncommon.

Coverage Denials and Conflicting Criteria

Despite the trial results, patients ‍like Middleton have faced denials from insurers like Cigna. These denials stipulated Ziihera coverage was contingent ‌on prior HER2 drug use – a direct contradiction of the trial’s inclusion criteria.

According to a text message from Dr. Palmeri, “there‍ is no evidence to use Ziihera AFTER prior HER2 therapy.” highlighting the discrepancy between the drug’s approved use and insurance requirements.

Potential as a “Game-Changer”

Dr.Douglas Rubinson, a senior physician specializing in gastrointestinal cancers at ​Dana-Farber Cancer Institute in Boston, ⁣believes​ Ziihera “might be the first⁢ big game-changer targeting HER2” in gastrointestinal cancers. However, he‍ cautioned against assuming a liver transplant would guarantee a cure for patients like Middleton.