USFDA released a drug safety communication for the updated significant safety information of the cancer medicine – umbralisib to disseminate awareness for optimal, safe & effective usage of this product in patients suffering from cancer of the lymph nodes and respective healthcare professionals involved in treating this patients.

Ukoniq (umbralisib) is a cancer medicine used in the treatment of below two specific types of lymphomas. It is a PI3 kinase inhibitor, which controls the multiplication and spreading of cancer cells by blocking the signaling action of abnormal protein.

  1. Marginal zone lymphoma (MZL)
  2. Follicular lymphoma (FL)

It was stated that recent results from UNITY clinical trial [Feb-2022], showed a possible increased risk of death and experiencing more serious adverse events in patients receiving the combination of umbralisib and the monoclonal antibody compared to the control arm.

USFDA advises patients and healthcare professionals to be aware and consider this updated safety information for continuous evaluation of benefits and risks based on individual patient-specific conditions.

Meanwhile, USFDA suspended further enrollment of patients to this clinical trial and started further evaluation of results from the UNITY trial for the communication of final recommendations and conclusion of the safety data review.

 Voluntary ADR reporting:

Every medicinal product has both benefits and risks. Medicines are authorized to market based on the favorable benefit-risk profile anticipated at the time of regulatory approval/entry into market. However, the safety profile of medicine would continuously updates owing to safety data from the post marketing experience from public. If the rate of reporting of suspected adverse drug reactions (ADR) from public is line with the actual occurrence of ADRs, the time lapse for taking regulatory action can be reduced and thereby improving patient safety.

All health care professionals and consumers of pharmaceutical medicinal products are encouraged to be aware of this fact and observe/monitor for any possible adverse events, reactions, medication errors, or quality complaints of medicinal products and report the same to your respective national health authority.

This would accumulate safety evidence for medicinal products which in turn help health authorities to take regulatory actions at the earliest possibility for a better patient safety and overall public health.

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