FDA record · Cancer
What FDA's own documents say about Beqalzi: what it is approved for, the trials FDA reviewed, the results it reported and the risks on the label.
“BEQALZI is a BCL-2 inhibitor indicated for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL) after at least two lines of systemic therapy, including a Bruton's tyrosine kinase (BTK) inhibitor.”
Prescribing Information (Label) · PDF p. 2 · fda.gov ↗
| Trial | ClinicalTrials.gov | Phase | Mentions | Documents |
|---|---|---|---|---|
| BGB-11417-201 | NCT05471843 | 1/2 | 177 | 7 of 11 |
| BGB-11417-101 | NCT04277637 | 1 | 61 | 2 of 11 |
| Study 180 | not given | 28 | 4 of 11 | |
| BGB-11417-102 | NCT04883957 | 1 | 24 | 2 of 11 |
| BGB-11417-202 | NCT05479994 | 2 | 17 | 2 of 11 |
| BGB-11417-103 | NCT04771130 | 1/2 | 14 | 1 of 11 |
| BGB-11417-107 | NCT06543043 | 1 | 10 | 1 of 11 |
| BGB-11417-302 | NCT06742996 | 3 | 6 | 2 of 11 |
| BGB-11417-106 | NCT05844111 | 1 | 4 | 1 of 11 |
Mentions: how many sentences across the FDA documents name the trial. NCT ids are read from the documents or, where they give none, matched on ClinicalTrials.gov by the trial's name or protocol code.
Sentences from FDA's reviews that give an endpoint's p-value, effect or confidence interval, those reporting a treatment effect first.
BGB-11417-201 · ORR
“The registrational trial, Study 201 supporting this application, met the primary endpoint, demonstrating a statistically significant improvement in ORR by IRC (52.4%, n=103) compared to the predefined historical control of 30% (p < 0.0001) in the 320 mg once daily group.”
Risk Assessment / REMS Review · PDF p. 4 · fda.gov ↗
52.4%p < 0.000130%
ORR
“ORR by IRC (52.4%, n=103) compared to the predefined historical control of 30% (p < 0.0001) in the 320 mg once daily total group (FDA Multi-Disciplinary Review and Evaluation 2026).e The clinical reviewer concludes the data support that sonrotoclax provides meaningful advantage in the context of ava”
Risk Assessment / REMS Review · PDF p. 8 · fda.gov ↗
52.4%p < 0.000130%
“The most common adverse reactions (>=15%) are pneumonia and fatigue.”
Prescribing Information (Label) · PDF p. 2 · fda.gov ↗
“After completion of the 4-week ramp-up phase, the recommended dosage of BEQALZI is 320 mg (four 80 mg tablets) taken orally once daily until disease progression or unacceptable toxicity.”
Prescribing Information (Label) · PDF p. 4 · fda.gov ↗
| Document | Date | Pages | Copy | sha256 |
|---|---|---|---|---|
| Approval letter220711Orig1s000ltr.pdf | May 15, 2026 | 10 | 2faa651ae5b9 | |
| Prescribing information, original approval220711Orig1s000lbl.pdf | June 1, 2026 | 24 | 7aa8a030bf7e | |
| Administrative Correspondence220711Orig1s000AdminCorres.pdf | June 10, 2026 | 20 | e618d5b997ac | |
| Approval Letter220711Orig1s000Approv.pdf | June 10, 2026 | 13 | 3be60b65aa06 | |
| Chemistry Review220711Orig1s000ChemR.pdf | June 10, 2026 | 62 | 91dd89ffbe7f | |
| Prescribing Information (Label)220711Orig1s000Lbl.pdf | June 10, 2026 | 48 | fa600581b7ff | |
| Multi-disciplinary Review220711Orig1s000MultidisciplineR.pdf | June 10, 2026 | 198 | 241dafba5882 | |
| Proprietary Name Review220711Orig1s000NameR.pdf | June 10, 2026 | 37 | 9a0965004808 | |
| Officer/Employee List220711Orig1s000OEList.pdf | June 10, 2026 | 3 | 3e6ac97937b1 | |
| Other Reviews220711Orig1s000OtherR.pdf | June 10, 2026 | 67 | 6b779d576b1b | |
| Risk Assessment / REMS Review220711Orig1s000RiskR.pdf | June 10, 2026 | 13 | 70760e72492b |
Checked against FDA's copies on September 29, 2026. The sha256 is the fingerprint of the file that was read: download it from fda.gov and compare. Quotes come from the text of each file as read; pages FDA stored as images were read by OCR and are marked.
Generated automatically (auto): the trials, names and dates are drafted from the documents by rules, with no language model; see the method.