Bayer pulls batch of cancer med Vitrakvi over bacterial contamination concerns

2023-11-20

临床3期临床结果微生物疗法

Bayer pulls batch of cancer med Vitrakvi over bacterial contamination concerns

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来源: FiercePharma

So far, Bayer has yet to receive any side effect reports tied to the recalled Vitrakvi batch.

The threat of microbial contamination has triggered yet another drug recall, this time from German pharma bigwig Bayer.

Bayer is recalling one lot of Vitrakvi oral solution in the U.S. after routine stability testing discovered the presence of microbial contamination identified as Penicillium brevicompactum. Specifically, Bayer is pulling one batch of Vitrakvi 20 mg/mL in 100-mL glass bottles.

So far, Bayer has yet to receive any side effect reports tied to the recalled Vitrakvi batch, though the contamination scare could cause problems given that the drug—indicated for the treatment of NTRK gene fusion-positive solid tumors NTRK gene fusion-positive solid tumors—is used by patients who may be immunocompromised.

Data on human exposure to Penicillium brevicompactum are scarce, Bayer pointed out. Nevertheless, cases of invasive disease have been caused by similar Penicillium species, particularly in patients with underlying immunosuppression, the company said in a press release.

For that reason, Bayer figures the tainted Vitrakvi batch could lead to fungal infections of the blood or potentially life-threatening pneumonia.

The suspect lot was due to expire Feb. 29, 2024, Bayer said. The batch was distributed to wholesale distributors and specialty pharmacies around the world between January and February of this year.

Bayer says it notified its customers of the recall Nov. 8. The company has also enlisted return management outfit Qualanex to chip in on the product pull.

Patients in possession of the recalled Vitrakvi should immediately stop using the drug and get in touch with their doctor or healthcare provider, Bayer added.

Bayer has had a rough stretch over the past couple days. Aside from the Vitrakvi recall, the company recently revealed its factor XIa inhibitor factor XIa inhibitor asundexian missed the mark in a phase 3 trial against Bristol Myers Squibb and Pfizer’s Eliquis, prompting Bayer to stop the study early.

The late-stage study, OCEANIC-AF, randomized patients with atrial fibrillation at risk for stroke to receive asundexian or Eliquis. An interim look at the data showed an independent data monitoring committee that asundexian had inferior efficacy compared to the control arm, leading it to recommend stopping the trial.

Elsewhere, microbial contamination has spurred a number of other drug recalls in 2023.

Back in April, Camber Pharmaceuticals pulled one lot of atovaquone oral suspension used to treat a form of pneumonia due to the presence of Bacillus cereus.

Meanwhile, VistaPharm in September said it was recalling one lot of sucralfate oral suspension—a popular ulcer treatment—because the drug was also contaminated with Bacillus cereus. The bacterium behind both recalls is often associated with food poisoning.