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The following information helps you to find FDA Alerts and Pharmacist’s Applications to Practice quickly and easily. In cooperation with the Food and Drug Administration (FDA), and as a service to our members, HOPA periodically distributes information about newly approved therapies for cancer patients from FDA’s Office of Oncology Drug Products Director, Dr. Richard Pazdur to inform oncologists and professionals in oncology-related fields in a timely manner. Links to product labels will take you to relevant clinical information on the indication, contraindications, dosing, and safety. In sending this information, HOPA does not endorse any product or therapy and does not take any position on the safety or efficacy of the product or therapy described.

Along with HOPA’s Publications Committee, members also review new drug updates and provide analysis and research on the application of these new drugs or indications. Pharmacist’s Applications to Practice, or PAP, are listed after drugs that include the additional analysis. If you are interested in helping the Publications Committee with creating a Pharmacist's Application to Practice, please contact Jeff Price at jprice@hoparx.org.

You can also find additional information on FDA Alerts and Updates by listening to FDA Drug Safety Podcasts.


March 20, 2018–Brentuximab vedotin (Adcetris®, Seattle Genetics, Inc.) to treat adult patients with previously untreated stage III or IV classical Hodgkin lymphoma (cHL) in combination with chemotherapy. (With Pharmacist's Applications to Practice)

November 9, 2017–Brentuximab vedotin (ADCETRIS, Seattle Genetics, Inc.) 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.(With Pharmacist's Applications to Practice)

August 17, 2015–Brentuximab vedotin (ADCETRIS) approved for the post-autologous hematopoietic stem cell transplantation (auto-HSCT) consolidation treatment of patients with classical Hodgkin lymphoma (HL) at high risk of relapse or progression.


March 20, 2018, with PAP

https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125388s097lbl.pdf

On March 20, 2018, the Food and Drug Administration approved brentuximab vedotin (Adcetris®, Seattle Genetics, Inc.) to treat adult patients with previously untreated stage III or IV classical Hodgkin lymphoma (cHL) in combination with chemotherapy.

Approval was based on a randomized, open-label, two-arm, multicenter trial, ECHELON-1, that randomized 1,334 patients to receive either Adcetris plus doxorubicin, vinblastine, and dacarbazine (Adcetris + AVD) or bleomycin plus AVD (ABVD). Patients were randomized to receive up to 6 cycles of Adcetris + AVD or ABVD on Days 1 and 15 of each 28-day cycle.

Efficacy was established based on modified progression-free survival (mPFS), defined as progression, death, or receipt of additional anticancer therapy for patients who are not in a complete response after completion of frontline therapy. The estimated median mPFS was not reached in either arm, with a median follow-up time of 24.6 months. There were 117 events (18%) on the Adcetris + AVD arm and 146 events (22%) on the ABVD arm (hazard ratio 0.77; 95% CI: 0.60, 0.98; p=0.035), corresponding to a 23 percent reduction in the risk of an mPFS event. At the time of the mPFS analysis, an interim overall survival analysis did not demonstrate a significant difference.

The most common adverse reactions in at least 20% of patients treated with Adcetris across all clinical trials were neutropenia, anemia, peripheral sensory neuropathy, nausea, fatigue, constipation, diarrhea, vomiting, and pyrexia. Primary G-CSF prophylaxis is recommended with Adcetris plus chemotherapy for the frontline treatment of stage III or IV cHL.

The recommended dose of Adcetris in combination with chemotherapy for previously untreated stage III or IV cHL is 1.2 mg/kg as an intravenous infusion up to a maximum of 120 mg every 2 weeks for 12 doses.

Full prescribing information is available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125388s097lbl.pdf

FDA granted this application priority review and breakthrough designation. A description of FDA expedited programs is in the Guidance for Industry: Expedited Programs for Serious Conditions-Drugs and Biologics, available at: http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm358301.pdf

Healthcare professionals should report all serious adverse events suspected to be associated with the use of any medicine and device to FDA’s MedWatch Reporting System by completing a form online at http://www.fda.gov/medwatch/report.htm, by faxing (1-800-FDA-0178) or mailing the postage-paid address form provided online, or by telephone (1-800-FDA-1088).


Pharmacist’s Applications to Practice

Brentuximab Vedotin for Adult Patients with Previously Untreated Stage III or IV Classic Hodgkin Lymphoma in Combination with Chemotherapy

Author: Aaron Cumpston, PharmD BCOP
Pharmacy Clinical Specialist, Bone Marrow Transplantation/Hematological Malignancy
West Virginia University Medicine
Morgantown, WV

What is the potential role for brentuximab vedotin in the treatment of classic Hodgkin lymphoma?

  • On March 20, 2018, the U.S. Food and Drug Administration (FDA) approved brentuximab vedotin (BV) for the treatment of adult patients with previously untreated stage III or stage IV classic Hodgkin lymphoma (cHL) in combination with chemotherapy.
  • The National Comprehensive Cancer Network recommends use of BV as a primary treatment for cHL (in patients age >18 years) in combination with doxorubicin, vinblastine, and dacarbazine (AVD) for stage III and stage IV disease.1
    • A category 2A recommendation is given if the patient has no known neuropathy and if the patient has an International Prognostic Score (IPS) of 4 or greater or if bleomycin is contraindicated.
    • A category 2B recommendation is given for all other patients.
  • BV is an antibody drug conjugate targeting CD30. It consists of a monoclonal antibody specific to CD30, attached with a linker molecule to the microtubule agent monomethyl auristatin E (MMAE). When the drug conjugate binds to CD30, the compound is internalized into the cell, where the linking peptide is cleaved, releasing the MMAE component.2
  • Approval of BV in the upfront treatment of cHL was based on an open-label multicenter randomized phase 3 trial comparing the standard therapy of ABVD (doxorubicin, bleomycin, vinblastine, and dacarbazine) to A+AVD (BV 1.2 mg/kg substituted for bleomycin).3
    • The study included 1,334 patients.
    • The 2-year modified progression-free survival (PFS) was 77.2% with ABVD, compared to 82.1% with A+AVD (p = .03).
    • At median follow-up of 25 months, there were 39 deaths with ABVD compared to 28 deaths with A+AVD (p = .19)
    • Rates of neutropenia (58% vs. 45%), febrile neutropenia (19% vs. 8%), and peripheral neuropathy (67% vs. 43%) were higher with A+AVD.
    • Grade 3 or higher pulmonary toxicity was reported in 1% of A+AVD patients and 3% of ABVD patients.

What role can the pharmacist play in the management of patients on BV + AVD chemotherapy?

  • BV dosing (1.2 mg/kg) in this regimen is lower than the single-agent dosing (1.8 mg/kg). A dose cap of 120 mg was used in the study.3
  • BV use should be avoided in patients with severe renal insufficiency (creatinine clearance [CrCl] <30 ml/min) or moderate/severe hepatic impairment (Child-Pugh class B or C).
    • Reduce dose to 0.9 mg/kg in patients with mild liver impairment (Child-Pugh class A).
  • MMAE is partially metabolized by cytochrome P450 3A4, and strong inhibitors or inducers could affect systemic exposure.
    • Coadministration of BV with ketoconazole resulted in approximately a 34% increase in MMAE exposure.
  • Concomitant use of BV and bleomycin is contraindicated because of the increased risk of pulmonary toxicity.
  • The most common grade 3 and grade 4 adverse effects include myelosuppression and peripheral neuropathy.
    • Neuropathy is considered cumulative and commonly reversible.
    • Primary prophylaxis with granulocyte colony-stimulating factor (GCSF) is recommended with the A+AVD regimen.
      • Following an interim analysis of the phase 3 trial, routine GCSF use was implemented for the remainder of the study because of the high rates of febrile neutropenia.
      • With implementation of growth factor support, the rates of febrile neutropenia were reduced from 21% to 11%, and the occurrence of grade 3 or higher infections was reduced from 18% to 11%.
    • Pharmacists should educate patients about peripheral neuropathy and encourage them to notify the medical provider if symptoms occur.
  • Financial assistance may be available from the manufacturer for patients who have no insurance or who have commercial or private insurance but need assistance with copays.  More information is available at www.SeaGenSecure.com.

Clinical Pearls

  • Evidence shows that removal of bleomycin from the ABVD regimen after two cycles in patients with negative positron emission tomography (PET) findings (a Deauville score of 1–3) reduces pulmonary toxicity and has no impact on disease relapse.4 Implementation of this strategy into ABVD therapy would make the benefits of A+AVD regarding pulmonary toxicity less meaningful. In this case the toxicity profile would favor ABVD, because substantially higher neuropathy was present with A+AVD.
  • Skepticism exists about the lack of survival benefit in the study and also the lack of long-term follow-up. Extensive long-term data are available with the ABVD regimen in cHL patients.
  • The cost of A+AVD is substantially higher than that of ABVD. Including pegfilgrastim with A+AVD brings the total cost of therapy in the United States to approximately $850,000, compared to approximately $8,000 for ABVD therapy.5
  • BV is an agent commonly used in the relapsed or refractory setting of cHL. Incorporation into the upfront treatment could limit options for these patients. The impact on long-term survival is unknown.

References

  1. National Comprehensive Cancer Network. Hodgkin Lymphoma. Version 3.2018. Available at https://www.nccn.org/professionals/physician_gls/pdf/hodgkins.pdf. Accessed April 20, 2018.
  2. Bradley AM, Devine M, DeRemer D. Brentuximab vedotin: an anti-CD30 antibody-drug conjugate. Am J Health Syst Pharm. 2013;70:589-597.
  3. Connors JM, Jurczak W, Straus DJ, et al. Brentuximab vedotin with chemotherapy for stage III or IV Hodgkin’s lymphoma. N Engl J Med. 2018;378:331-344.
  4. Johnson P, Federico M, Kirkwood A, et al. Adapted treatment guided by interim PET-CT scan in advanced Hodgkin’s lymphoma. N Engl J Med. 2016;374:2419-2429.
  5. Greer JP. Brentuximab vedotin for stage III or IV Hodgkin’s lymphoma. N Engl J Med. 2018;378:1559.

November 9, 2017 with PAP

https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125388s094lbl.pdf

On November 9, 2017, the Food and Drug Administration granted regular approval to brentuximab vedotin (ADCETRIS®, Seattle Genetics, Inc.) 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.

Approval was based on a phase 3, randomized, open-label, multicenter clinical trial (ALCANZA) of brentuximab vedotin in patients with MF or pcALCL who had previously received one prior systemic therapy and required systemic treatment. The trial randomized 131 patients (1:1) to receive either brentuximab vedotin or the physician’s choice of methotrexate or bexarotene.

Efficacy was established based on improvement in objective response rate lasting 4 months (ORR4), complete response (CR) rate, and progression-free survival (PFS) assessed by an independent review facility. ALCANZA demonstrated an improvement (p<0.001) in ORR4 in the brentuximab vedotin arm versus the physician’s choice arm, 56% (95% CI: 44%, 68%) versus 12% (95% CI 4%, 21%), respectively. CR rate was also superior (p=0.007) in the brentuximab vedotin arm versus the physician’s choice arm, 16% (95% CI: 8%, 27%) versus 2% (95%CI: 0, 8%). ALCANZA also demonstrated improvement in PFS with an estimated hazard ratio of 0.27 (95%CI 0.17, 0.43, p<0.001). The median PFS was 17 months in the brentuximab vedotin arm versus 4 months in the physician’s choice arm.

The most common adverse reactions occurring in >20% of patients receiving brentuximab vedotin were anemia, peripheral sensory neuropathy, nausea, diarrhea, fatigue, and neutropenia. The most common adverse event leading to discontinuation was peripheral neuropathy.

The recommended dose of brentuximab vedotin is 1.8 mg/kg up to a maximum of 180 mg as an intravenous infusion over 30 minutes every 3 weeks until a maximum of 16 cycles, disease progression, or unacceptable toxicity.

Full prescribing information is available at:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125388s094lbl.pdf

FDA granted Breakthrough Therapy Designation, Orphan Designation, and priority review to brentuximab vedotin for this indication. A description of FDA expedited programs is in the Guidance for Industry: Expedited Programs for Serious Conditions-Drugs and Biologics, available at:
http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm358301.pdf

Healthcare professionals should report all serious adverse events suspected to be associated with the use of any medicine and device to FDA’s MedWatch Reporting System by completing a form online at http://www.fda.gov/medwatch/report.htm, by faxing (1-800-FDA-0178) or mailing the postage-paid address form provided online, or by telephone (1-800-FDA-1088).


Pharmacist's Applications to Practice

Brentuximab Vedotin for Adult Patients with Primary Cutaneous Anaplastic Large Cell Lymphoma or CD30-Expressing Mycosis Fungoides Who Have Received Prior Systemic Therapy

Author: Elizabeth R. Pritchard, PharmD BCOP
Assistant Professor, Pharmacy Practice
College of Pharmacy
University of Arkansas for Medical Sciences
Little Rock, AR

What is the potential role for brentuximab vedotin (BV) in the treatment of primary cutaneous anaplastic large cell lymphoma (pcALCL) and CD30-expressing mycosis fungoides (MF)?

  • BV is a CD30-directed antibody-drug conjugate (ADC) composed of chimeric IgG1 directed against CD30, a protease linker, and monomethyl auristatin E (MMAE), a microtubule-disrupting agent. MMAE is internalized after the antibody binds to CD30-expressing cells, leading to cell-cycle arrest and apoptosis. BV is the only approved ADC for the treatment of pcALCL and MF.1,2
  • In November 2017, BV was granted regular approval by the U.S. Food and Drug Administration (FDA) for the treatment of adult patients with pcALCL and CD30-expressing MF who had previously received one prior systemic therapy based on data from the phase 3 ALCANZA trial.3
    • In ALCANZA, BV demonstrated an improvement in objective response rate (ORR) lasting 4 months, complete response (CR), and progression-free survival (PFS) over physician’s choice of treatment, which included methotrexate or bexarotene.4
      • ORR lasting 4 months was significantly improved (p < .001) in the BV arm versus the physician’s-choice arm: 56% (95% confidence interval [CI]: 44%, 68%) versus 12% (95% CI: 4%, 21%), respectively.
      • CR rate was also superior (p = .007) in the BV arm versus the physician’s-choice arm, 16% (95% CI: 8%, 27%) versus 2% (95% CI: 0, 8%).
      • Median PFS was 17 months in the BV arm versus 4 months in the physician’s choice arm. Improvement in PFS with an estimated hazard ratio of 0.27 (95% CI 0.17, 0.43, < .001).
  • The National Comprehensive Cancer Network (NCCN) Guidelines updated the T-Cell Lymphoma Guidelines on the basis of the ALCANZA data:5
    • For pcALCL with multifocal lesions, BV is the preferred regimen as primary treatment and a category-1 recommendation.
    • For cutaneous ALCL with regional node (excluding systemic ALCL), BV ± involved-site radiation therapy (ISRT) is the preferred regimen.
    • For refractory MF, BV was added to Category A for suggested treatment regimens as a category-2A recommendation.

What role can the pharmacist play in the management of patients on BV?1,2

  • Recommended dosing of BV is 1.8 mg/kg up to a maximum of 180 mg as an intravenous infusion over 30 minutes every 3 weeks until a maximum of 16 cycles, progression of the disease, or an unacceptable level of toxicity.
  • Recommended dosing for hepatic impairment:
    • For patients with mild hepatic impairment (Child-Pugh A), the dose is reduced to 1.2 mg/kg (maximum 120 mg).
    • For patients with moderate (Child-Pugh B) to severe (Child-Pugh C) hepatic impairment, use of BV is not recommended because of an increase of adverse reactions grade 3 or greater in clinical trials.
  • For patients with severe renal impairment (creatinine clearance [CrCl] less than 30 ml/min), use of BV is not recommended because of an increase of adverse reactions grade 3 or greater found in a phase 1 open-label pharmacokinetic trial of BV in patients with hepatic and renal impairment. Of note, the trial was not designed to evaluate differences between patients in treatment arms.
  • For patients weighing more than 100 kg, the dose should be calculated based on a weight of 100 kg.
  • Dose modifications are provided in the package insert for peripheral neuropathy and neutropenia.1
  • The most common adverse reactions of any grade in the ALCANZA trial included peripheral neuropathy (67%), nausea (36%), diarrhea (29%), and fatigue (29%).4 These rates are similar to those in previous trials.1 However, neutropenia is also a known toxicity of BV (any grade: 54%–78%; grade 3: 12%–30%; grade 4: 6%–9%) and should be monitored. Other common (20% or less) adverse effects per the principal investigator (PI) include anemia, upper respiratory tract infection, pyrexia, rash, thrombocytopenia, cough, and vomiting.1 In the ALCANZA trial the rates of those adverse effects were as follows: anemia (5%), upper respiratory tract infection (not reported), pyrexia (17%), rash (11%), thrombocytopenia (not reported), cough (not reported), and vomiting (17%).3
    • Peripheral neuropathy, primarily sensory, is common, and cumulative toxicity is associated with BV.1 Median time to onset is typically 13 weeks (range 0–52 weeks). Of the patients who experienced neuropathy, 62% had complete resolution at the last evaluation. Monitor patients for signs and symptoms of peripheral neuropathy and implement dose modifications, as necessary.
    • BV is classified as having a low emetic risk, and appropriate antiemetic premedications should be provided.2
  • Patient support services, including financial assistance, are offered through SeaGen Secure by calling 855.473.2873 or visiting https://adcetris.com/treatment/costs.

Clinical Pearls

  • BV is supplied in 50-mg single-dose vials.1,2 Vials should be reconstituted with Sterile Water for Injection, USP, with the stream toward the wall of the vial. To aid in dissolution, it is recommended that the vial be gently swirled. BV solution should then be added to an infusion bag (minimum volume 100 ml) to achieve a final concentration of .4 mg/ml to 1.8 mg/ml. The solution may be added to .9% Sodium Chloride Injection, 5% Dextrose Injection, or Lactated Ringer's Injection.
  • In ALCANZA, CD30 positivity was defined as CD30 expression greater than 10% of total lymphoid cells in at least one of minimal two skin biopsies.4 Forty-four percent of eligible patients with MF had at least one screening skin biopsy with CD30 less than 10%. Of note, in two previously reported investigator-initiated studies, clinical responses with BV were observed across all CD30 expression levels, including those with negligible CD30 expression.7,8 Per the PI, patients should have CD30-expressing MF to receive this therapy.1
  • It is important to note that, although not related to this new indication for BV, concomitant use of BV with bleomycin is contraindicated because of the higher rate of noninfectious pulmonary toxicity in patients with classical Hodgkin lymphoma (cHL) who received combination of BV with ABVD (adriamycin, bleomycin, vinblastine, dacarbazine) compared to the historic control of ABVD alone.1,9 In the AETHERA trial, pulmonary toxicity was reported in 8 patients receiving BV for cHL consolidation post autologous hematopoietic stem cell transplant (auto-HSCT).10
  • Progressive multifocal leukoencephalopathy (PML) is a black-box warning for BV. PML is a rare but fatal central nervous system infection caused by reactivation of the latent JC virus, a type of human polyomavirus.1,2 PML was reported in patient who received BV for systemic ALCL.2 PML was not observed in BV patients in the ALCANZA trial.4 PML is suspected based on neurological changes that may include confusion, vision changes, speech changes, motor weakness, and poor motor coordination. Neurological changes warrant further investigation. Diagnosis is made by polymerase chain reaction (PCR) of cerebrospinal fluid (CSF) or, in some cases, brain biopsy. There is no known effective treatment or current standards of pretreatment evaluations for PML.

References

  1. Adcetris (brentuximab vedotin) [package insert]. Bothell, WA: Seattle Genetics; November 2017.
  2. Lexi-Drugs Online, Hudson, OH: Lexi-Comp, Inc.; 2013; Accessed December 27, 2017.
  3. Brentuximab vedotin. U.S. Food and Drug Administration: Approved Drugs. November 9, 2017. https://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm584543.htm. Accessed December 27, 2017.
  4. 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;390(10094):555-566.
  5. T-Cell Lymphomas. Version 1.2018. National Comprehensive Cancer Network. Accessed November 9, 2017.
  6. Zhao B, Chen R, O’Connor OA, et al. Brentuximab vedotin, an antibody drug conjugate, in patients with CD30-positive haematologic malignancies and hepatic or renal impairment. Br J Clin Pharmacol. 2016;82(3):696-705.
  7. Duvic M, Tetzlaff M, Gangar P, et al. Results of a phase ll trial of brentuximab vedotin for CD30+ cutaneous T-cell lymphoma and lymphomatoid papulosis. J Clin Oncol. 2015;33:3759-3765.
  8. Kim YH, Tavallaee M, Sundram U, et al. Phase II investigator-initiated study of brentuximab vedotin in mycosis fungoides and Sezary syndrome with variable CD30 expression level: a multi-institution collaborative project. J Clin Oncol. 2015;33:3750-3758.
  9. Ansell MS, Connors JM, Park SI, O’Meara M, Younes A. Frontline therapy with brentuximab vedotin combined with ABVD or AVD in patients with newly diagnosed advanced stage Hodgkin lymphoma. Blood (ASH Annual Meeting Abstracts). 2012;120:798.
  10. Moskowitz CH, Nademanee A, Masszi T, et al. Brentuximab vedotin as consolidation therapy after autologous stem-cell transplantation in patients with Hodgkin's lymphoma at risk of relapse or progression (AETHERA): a randomised, double-blind, placebo-controlled, phase 3 trial [published correction appears in Lancet. 2015;386(9993):532]. Lancet. 2015;385(9980):1853-1862.

August 17, 2015

http://amc-hopa.informz.net/amc-hopa/data/images/FDA%208-18-15.pdf

On August 17, 2015, the U. S. Food and Drug Administration approved brentuximab vedotin (ADCETRIS) for the post-autologous hematopoietic stem cell transplantation (auto-HSCT) consolidation treatment of patients with classical Hodgkin lymphoma (HL) at high risk of relapse or progression.

The approval was based on a randomized, double-blind, placebo controlled clinical trial in 329 patients with classical HL at high risk of relapse or progression based on pre-transplant factors. Following an auto-HSCT, patients were randomized (1:1) to brentuximab vedotin or placebo once every three weeks for a maximum of 16 cycles. The high risk category was defined as one of the following according to status after initial therapy: refractory classical HL, relapsed disease occurring within 12 months, or relapsed disease with extra-nodal involvement. Patients ranged in age from 18-76 years (median 32 years). Patients had received a median of 2 prior systemic therapies (range 2-8) excluding auto-HSCT.

The trial demonstrated a statistically significant improvement in the primary efficacy endpoint of progression free survival (PFS) determined by an independent review facility. The median PFS in the brentuximab vedotin arm was 42.9 months compared to 24.1 months in the placebo arm [Hazard Ratio 0.57 (95% CI 0.40, 0.81; p=0.001)]. At the time of the PFS analysis, an interim analysis of overall survival demonstrated no difference. Patients in the placebo arm could receive ADCETRIS as part of a separate trial after disease progression.

The most common adverse reactions (greater than or equal to 20%) in patients treated with brentuximab vedotin, regardless of causality, were neutropenia, peripheral sensory neuropathy, thrombocytopenia, anemia, upper respiratory tract infection, fatigue, peripheral motor neuropathy, nausea, cough and diarrhea. Twenty-five percent of patients reported serious adverse reactions. The most common serious adverse reactions were pneumonia, pyrexia, vomiting, nausea, hepatotoxicity, and peripheral sensory neuropathy.

Of the patients treated with brentuximab vedotin, infusion-related reactions were reported in 25 patients (15%) and pulmonary toxicity was reported in 8 patients (5%). Any grade of neuropathy was reported in 67%. Of the patients who reported neuropathy, 59% had complete resolution and 41% had residual neuropathy. Adverse reactions leading to dose delays in more than 5% of patients were neutropenia, peripheral sensory neuropathy, upper respiratory tract infection, and peripheral motor neuropathy. Adverse reactions led to treatment discontinuation in 32%. Adverse reactions that led to treatment discontinuation in 2 or more patients were peripheral sensory neuropathy, peripheral motor neuropathy, acute respiratory distress syndrome, paraesthesia and vomiting.

The recommended dose and schedule for brentuximab vedotin as post-auto-HSCT consolidation is 1.8 mg/kg administered intravenously over 30 minutes every 3 weeks. Treatment should be initiated within 4-6 weeks after auto-HSCT or upon recovery from transplantation. The patient should continue treatment until a maximum of 16 cycles, disease progression, or unacceptable toxicity.

Full prescribing information, including clinical trial information, safety, dosing, drug-drug interactions and contraindications is available here.

Healthcare professionals should report all serious adverse events suspected to be associated with the use of any medicine and device to FDA’s MedWatch Reporting System by completing a form online at http://www.fda.gov/medwatch/report.htm, by faxing (1-800-FDA-0178) or mailing the postage-paid address form provided online, or by telephone (1-800-FDA-1088).

 

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