BRUKINSA patients can call the myBeOne Support™ program to talk to a dedicated nurse: 1-833-234-4363
DESIGNED TO EVALUATE EFFICACY AND SAFETY OF BRUKINSA + OBINUTUZUMAB IN FL PATIENTS AFTER ≥2 PRIOR THERAPIES
ROSEWOOD (STUDY 212)A global Phase 2, open-label, multicenter, randomized trial in 217 adult patients with relapsed or refractory FL after at least 2 prior systemic therapies. Patients were enrolled from Asia, Australia/New Zealand, North America, and Europe.1-3
*Obinutuzumab was given intravenously at 1000 mg in both arms on Days 1, 8, and 15 of Cycle 1; 1000 mg on Day 1 of Cycles 2 to 6; and then 1000 mg every 8 weeks, up to 20 doses maximum or until PD or unacceptable toxicity. Per investigator discretion, the Day 1 Cycle 1 obinutuzumab dose could be administered over 2 days (100 mg Day 1 and 900 mg Day 2).1
†Efficacy was based on ORR and DOR. The primary endpoint was ORR per IRC in the ITT population in the BRUKINSA + obinutuzumab arm and the obinutuzumab monotherapy arm, with the 2-sided p value of 0.0012 for superiority.1,2
‡In ROSEWOOD (Study 212), PET scans were required at baseline and after Cycles 3, 6, and 12 of treatment for response assessment.2
BID=twice daily; DOR=duration of response; FL=follicular lymphoma; IRC=independent review committee; ITT=intent to treat; ORR=overall response rate; PD=progressive disease; PET=positron emission tomography; PFS=progression-free survival.
| Baseline Patient Characteristics | BRUKINSA + obinutuzumab (n=145) | Obinutuzumab (n=72) | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Median age | 63 years (range: 31-84) | 66 years (range: 32-88) | |||||||||||||||
| Male | 52% | 46% | |||||||||||||||
| ECOG PS 0-1 | 97% | 99% | |||||||||||||||
| FLIPI score ≥3 | 53% | 51% | |||||||||||||||
| Bulky disease (≥7 cm) | 16% | 17% | |||||||||||||||
| |||||||||||||||||
| Refractory to rituximab | 54% | 50% | |||||||||||||||
| Ann Arbor stage III-IV | 82% | 83% | |||||||||||||||
| High tumor burden per GELF criteria | 57% | 56% | |||||||||||||||
| PD ≤24 months of starting first line of therapy | 34% | 42% | |||||||||||||||
Patients received a median of 3 prior lines of therapy and half were refractory to rituximab at trial initiation2
ECOG PS=Eastern Cooperative Oncology Group performance status; FLIPI=Follicular Lymphoma International Prognostic Index; GELF=Groupe d’Etude des Lymphomes Folliculaires; PD=progressive disease.
IMPORTANT SAFETY INFORMATION
What should I tell my healthcare provider before taking BRUKINSA?
Before taking BRUKINSA, tell your healthcare provider about all of your medical conditions, including if you:
- have bleeding problems.
- have had recent surgery or plan to have surgery. Your healthcare provider may stop BRUKINSA for any planned medical, surgical, or dental procedure.
- have an infection.
- have or had heart rhythm problems.
- have high blood pressure.
- have liver problems, including a history of hepatitis B virus (HBV) infection.
- are pregnant or plan to become pregnant. BRUKINSA can harm your unborn baby. If you are able to become pregnant, your healthcare provider may do a pregnancy test before starting treatment with BRUKINSA.
- Females should avoid getting pregnant during treatment and for 1 week after the last dose of BRUKINSA. You should use effective birth control (contraception) during treatment and for 1 week after the last dose of BRUKINSA.
- Males should avoid getting female partners pregnant during treatment and for 1 week after the last dose of BRUKINSA. You should use effective birth control (contraception) during treatment and for 1 week after the last dose of BRUKINSA.
- are breastfeeding or plan to breastfeed. It is not known if BRUKINSA passes into your breast milk. Do not breastfeed during treatment with BRUKINSA and for 2 weeks after the last dose of BRUKINSA.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Taking BRUKINSA with certain other medications may affect how BRUKINSA works and can cause side effects.
What are the possible side effects of BRUKINSA?
BRUKINSA may cause serious side effects, including:
- Bleeding problems (hemorrhage). Bleeding problems are common with BRUKINSA, and can be serious and may lead to death. Your risk of bleeding may increase if you are also taking a blood thinner medicine. Tell your healthcare provider if you have any signs or symptoms of bleeding, including:
- blood in your stools or black stools (looks like tar)
- pink or brown urine
- unexpected bleeding, or bleeding that is severe or you cannot control
- vomit blood or vomit that looks like coffee grounds
- cough up blood or blood clots
- increased bruising
- dizziness
- weakness
- confusion
- change in speech
- headache that lasts a long time
- Infections that can be serious and may lead to death. Tell your healthcare provider right away if you have fever, chills, or flu-like symptoms.
- Decrease in blood cell counts (white blood cells, platelets, and red blood cells). Your healthcare provider should do blood tests during treatment with BRUKINSA to check your blood counts.
- Second primary cancers. New cancers have happened in people during treatment with BRUKINSA, including cancers of the skin or other organs. Your healthcare provider will check you for other cancers during treatment with BRUKINSA. Use sun protection when you are outside in sunlight.
- Heart rhythm problems (atrial fibrillation, atrial flutter, and ventricular arrhythmias) that can be serious and may lead to death. Tell your healthcare provider if you have any of the following signs or symptoms:
- your heartbeat is fast or irregular
- feel lightheaded or dizzy
- pass out (faint)
- shortness of breath
- chest discomfort
- Liver problems. Liver problems, which may be severe or life-threatening, or lead to death, can happen in people treated with BRUKINSA. Your healthcare provider will do blood tests to check your liver before and during treatment with BRUKINSA. Tell your healthcare provider or get medical help right away if you have any signs of liver problems, including stomach pain or discomfort, dark-colored urine, or yellow skin and eyes.
The most common side effects of BRUKINSA include:
- decreased white blood cell count
- decreased platelet count
- upper respiratory tract infection
- bleeding
- muscle, bone, or joint pain
These are not all the possible side effects of BRUKINSA. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What is BRUKINSA?
BRUKINSA is a prescription medicine used to treat adults with:
- Chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).
- Waldenström’s macroglobulinemia (WM).
- Mantle cell lymphoma (MCL) who have received at least one prior treatment for their cancer.
- Marginal zone lymphoma (MZL) when the disease has come back or did not respond to treatment and who have received at least one certain type of treatment.
- Follicular lymphoma (FL), in combination with the medicine obinutuzumab, when the disease has come back or did not respond to treatment and who have received at least two prior treatments.
It is not known if BRUKINSA is safe and effective in children.
Please see full Prescribing Information including Patient Information.
