AbbVie and Johnson & Johnson’s Imbruvica are dropping two of their authorized uses as a result of competition from alternative medicines.
AbbVie and Johnson & Johnson said that they would voluntarily remove Imbruvica for the treatment of mantle cell lymphoma (MCL) and marginal zone lymphoma (MZL) in patients who have had prior treatment.
According to the firms, the fast approvals were withdrawn because the FDA was not convinced by the results of two phases 3 confirmatory trials.
Imbruvica Withdrawals and their Impact on AbbVie
- Low volume of patients with MCL and MZL treated with Imbruvica compared to primary indication CLL; withdrawals won’t affect CLL use
- Withdrawals hurt the Imbruvica brand despite limited usage in MCL and MZL treatment
- AbbVie’s 2022 US sales of Imbruvica were down 21% due to competition from Brukinsa and Calquence
- Imbruvica is at a disadvantage due to Brukinsa’s victory in CLL and recent FDA approvals
- Imbruvica phase 3 SHINE research showed a 25% lower likelihood of further progression or mortality in newly diagnosed MCL patients; MCL withdrawal unexpected
Nevertheless, results presented at the 2022 annual conference of the American Society of Clinical Oncology showed that the drug did not significantly increase the average survival time of its patients. Although many patients in the control group went on to get a BTK inhibitor after illness progression, vice president of oncology clinical development, Janssen Craig Tendler, downplayed the lackluster survival rates at the time.
However, an increasing rate of adverse effects, in addition to a lack of improvement in overall survival despite a positive finding in progression-free survival, allegedly triggered concern at the FDA. Earlier, the FDA had triggered the widespread withdrawal from the market of many PI3K inhibitors, also for blood malignancies, due to a similar trend of clinical results.
The FDA brought up the issue of safety as a metric of efficacy during last April’s advisory committee meeting examining the PI3K drug class. This is especially true when adverse effects appear to negatively impact patients’ long-term survival results, the FDA noted.
AbbVie and J&J reported that Imbruvica did not prevent cancer progression or mortality in individuals with previously treated MZL or follicular lymphoma in the phase 3 SELENE investigation. The parties stated that further in-depth information would be shared at a subsequent medical conference.
Tendler said in a statement, “We fully support the FDA accelerated approval pathway, which patients rely on for timely access to promising treatments that may improve or extend their lives.” He added that J&J is still confident in Imbruvica’s additional indications.
After Imbruvica’s formal withdrawal from these indications, Brukinsa from BeiGene will be the sole BTK inhibitor available in the U.S. for relapsed or refractory MZL – it got an expedited approval back in 2021.
In MCL, Jaypirca from Eli Lilly was recently approved as a late-line option, joining Brukinsa and Calquence from AstraZeneca, both of which have accelerated authorizations for patients who have already had one previous medication.
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