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Full Prescribing Information
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NOW APPROVED FOR pcALCL OR CD30-EXPRESSING MF
ADULT PATIENTS AFTER PRIOR SYSTEMIC THERAPY
SUPERIOR PFS, WITH SUSTAINED SEPARATION FROM COMPARATOR TREATMENT1,2
PFS (key secondary endpoint)
ADCETRIS® (brentuximab vedotin) is indicated for the treatment of adult patients with primary cutaneous anaplastic large cell lymphoma (pcALCL) or CD30-expressing mycosis fungoides (MF) who have received prior systemic therapy.1
Please see full Prescribing Information, including BOXED WARNING, here and see Important Safety Information here.
ADCETRIS: SUPERIOR RESPONSE SUSTAINED FOR ≥4 MONTHS VS COMPARATOR TREATMENT1,2
ORR4‌*: Primary endpoint per IRF
ORR SUSTAINED FOR ≥4 MONTHS P<0.001
56%
ADCETRIS
95% CI: 44.1, 68.4
13%
COMPARATOR TREATMENT
(METHOTREXATE OR BEXAROTENE) 95% CI: 4.4, 20.6
*ORR4 is calculated from the first response to the last response ≥4 months.1
CR, key secondary endpoint:
16% for ADCETRIS (95% CI: 7.8, 26.9) vs 2% for comparator treatment
(95% CI: 0, 8.4); P = 0.00661,2
PR:
52% for ADCETRIS (95% CI: 39.3, 63.8) vs 19% for comparator treatment
(95% CI: 9.2, 28.3)1
ORR (at any point), ad hoc exploratory analysis:
67% for ADCETRIS (95% CI: 55.7, 78.7) vs 20% for comparator treatment
(95% CI: 10.5, 30.2); P = 0.00011,2
Trial design
ALCANZA: a global, open-label, multicenter, randomized trial in 131 patients with CD30-expressing mycosis fungoides (MF) or primary cutaneous anaplastic large-cell lymphoma (pcALCL) evaluating single-agent ADCETRIS vs physician’s choice of methotrexate or bexarotene. Patients were randomized 1:1 and received either ADCETRIS 1.8 mg/kg intravenously every 3 weeks for up to 16 cycles (48 weeks) or physician’s choice of methotrexate 5-50 mg orally once weekly or bexarotene 300 mg/m2 orally once daily for up to 48 weeks. The primary endpoint was the rate of objective global response (complete or partial response) lasting at least 4 months (ORR4) as determined by an independent review facility (IRF). Progression-free survival (PFS) per IRF was a key secondary endpoint, calculated from randomization to date of disease progression or death (due to any cause).1
CR =
 complete response
PR =
 partial response
ORR =
 objective global response (complete or partial response)
Most common adverse events (≥10%) in patients treated with ADCETRIS
  • Anemia 62%
  • Peripheral sensory neuropathy 45%
  • Nausea 36%
  • Diarrhea 29%
  • Fatigue 29%
  • Neutropenia 21%
  • Pruritus 17%
  • Pyrexia 17%
  • Vomiting 17%
  • Alopecia 15%
  • Decreased appetite 15%
  • Thrombocytopenia 15%
  • Arthralgia 12%
  • Myalgia 12%
  • Asthenia 11%
  • Dyspnea 11%
  • Edema peripheral 11%
  • Pruritus generalized 11%
  • Rash maculo-papular 11%
The most common serious events in patients treated with ADCETRIS
  • Cellulitis 3%
  • Pyrexia 3%
Other approved ADCETRIS indications
IMPORTANT SAFETY INFORMATION,
BOXED WARNING AND INDICATION
Important Safety Information
BOXED WARNING
PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY (PML): JC virus infection resulting in PML and death can occur in ADCETRIS-treated patients.
Contraindication: ADCETRIS concomitant with bleomycin due to pulmonary toxicity (e.g., interstitial infiltration and/or inflammation).
Warnings and Precautions
  • Peripheral neuropathy (PN): ADCETRIS causes PN that is predominantly sensory. Cases of motor PN have also been reported. ADCETRIS-induced PN is cumulative. Monitor for symptoms such as hypoesthesia, hyperesthesia, paresthesia, discomfort, a burning sensation, neuropathic pain, or weakness. Institute dose modifications accordingly.
  • Anaphylaxis and infusion reactions: Infusion-related reactions (IRR), including anaphylaxis, have occurred with ADCETRIS. Monitor patients during infusion. If an IRR occurs, interrupt the infusion and institute appropriate medical management. If anaphylaxis occurs, immediately and permanently discontinue the infusion and administer appropriate medical therapy. Premedicate patients with a prior IRR before subsequent infusions. Premedication may include acetaminophen, an antihistamine, and a corticosteroid.
  • Hematologic toxicities: Prolonged (≥1 week) severe neutropenia and Grade 3 or 4 thrombocytopenia or anemia can occur with ADCETRIS. Febrile neutropenia has been reported with ADCETRIS. Monitor complete blood counts prior to each ADCETRIS dose. Consider more frequent monitoring for patients with Grade 3 or 4 neutropenia. Monitor patients for fever. If Grade 3 or 4 neutropenia develops, consider dose delays, reductions, discontinuation, or G-CSF prophylaxis with subsequent doses.
  • Serious infections and opportunistic infections: Infections such as pneumonia, bacteremia, and sepsis or septic shock (including fatal outcomes) have been reported in ADCETRIS-treated patients. Closely monitor patients during treatment for bacterial, fungal, or viral infections.
  • Tumor lysis syndrome: Closely monitor patients with rapidly proliferating tumor and high tumor burden.
  • Increased toxicity in the presence of severe renal impairment: The frequency of ≥Grade 3 adverse reactions and deaths was greater in patients with severe renal impairment compared to patients with normal renal function. Avoid use in patients with severe renal impairment.
  • Increased toxicity in the presence of moderate or severe hepatic impairment: The frequency of ≥Grade 3 adverse reactions and deaths was greater in patients with moderate or severe hepatic impairment compared to patients with normal hepatic function. Avoid use in patients with moderate or severe hepatic impairment.
  • Hepatotoxicity: Serious cases, including fatal outcomes, have occurred in ADCETRIS-treated patients. Cases were consistent with hepatocellular injury, including elevations of transaminases and/or bilirubin, and occurred after the first ADCETRIS dose or rechallenge. Preexisting liver disease, elevated baseline liver enzymes, and concomitant medications may increase the risk. Monitor liver enzymes and bilirubin. Patients with new, worsening, or recurrent hepatotoxicity may require a delay, change in dose, or discontinuation of ADCETRIS.
  • PML: JC virus infection resulting in PML and death has been reported in ADCETRIS-treated patients. First onset of symptoms occurred at various times from initiation of ADCETRIS, with some cases occurring within 3 months of initial exposure. Other possible contributory factors other than ADCETRIS include prior therapies and underlying disease that may cause immunosuppression. Consider PML diagnosis in patients with new-onset signs and symptoms of central nervous system abnormalities. Hold ADCETRIS if PML is suspected and discontinue ADCETRIS if PML is confirmed.
  • Pulmonary toxicity: Noninfectious pulmonary toxicity events including pneumonitis, interstitial lung disease, and acute respiratory distress syndrome, some with fatal outcomes, have been reported. Monitor patients for signs and symptoms, including cough and dyspnea. In the event of new or worsening pulmonary symptoms, hold ADCETRIS dosing during evaluation and until symptomatic improvement.
  • Serious dermatologic reactions: Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), including fatal outcomes, have been reported with ADCETRIS. If SJS or TEN occurs, discontinue ADCETRIS and administer appropriate medical therapy.
  • Gastrointestinal (GI) complications: Acute pancreatitis, including fatal outcomes, has been reported. Other fatal and serious GI complications include perforation, hemorrhage, erosion, ulcer, intestinal obstruction, enterocolitis, neutropenic colitis, and ileus. Lymphoma with preexisting GI involvement may increase the risk of perforation. In the event of new or worsening GI symptoms, including severe abdominal pain, perform a prompt diagnostic evaluation and treat appropriately.
  • Embryo-fetal toxicity: Based on the mechanism of action and animal studies, ADCETRIS can cause fetal harm. Advise females of reproductive potential of the potential risk to the fetus, and to avoid pregnancy during ADCETRIS treatment and for at least 6 months after the final dose of ADCETRIS.
Most Common (≥20%) Adverse Reactions: peripheral sensory neuropathy, fatigue, nausea, diarrhea, neutropenia, upper respiratory tract infection, and pyrexia.
Drug Interactions
Concomitant use of strong CYP3A4 inhibitors or inducers, or P-gp inhibitors, has the potential to affect the exposure to monomethyl auristatin E (MMAE).
Use in Specific Populations
Moderate or severe hepatic impairment or severe renal impairment: MMAE exposure and adverse reactions are increased. Avoid use.
Advise males with female sexual partners of reproductive potential to use effective contraception during ADCETRIS treatment and for at least 6 months after the final dose of ADCETRIS.
Indication
ADCETRIS® is indicated for adult patients with primary cutaneous anaplastic large cell lymphoma (pcALCL) or CD30-expressing mycosis fungoides (MF) who have received prior systemic therapy.
Please see full Prescribing Information, including BOXED WARNING
References
1. ADCETRIS [Prescribing Information]. Bothell, WA: Seattle Genetics, Inc.; November 2017.
2. Prince HM, Kim YH, Horwitz SM, et al. Brentuximab vedotin or physician's choice in CD30-positive cutaneous T-cell lymphoma (ALCANZA): an international, open-label, randomised, phase 3, multicentre trial. Lancet. 2017;309:555-556.
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