Generic Imatinib Therapy Among Jordanians: An Observational Assessment of Efficacy and Safety in Routine Clinical Practice

Awidi, Abdalla; Abbasi, Salah; Al-Rabi, Kamal; Kheirallah, Khalid A.

doi:10.1016/j.clml.2017.08.001

Cited by 11 publications

(16 citation statements)

References 19 publications

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“…The 12‐month progression‐free and overall survival rates were 92% and 100%, respectively, and most (85%; n = 144) adverse events were mild. The authors concluded that the efficacy and safety of GI was comparable to that of BI in their Middle Eastern population . The largest cohort investigated comes from a study in India, which compared 1067 patients treated with BI with 144 patients treated with GI.…”

Section: Introductionmentioning

confidence: 83%

“…23 In an observational study from Jordan, the efficacy and safety of GI in 91 adult patients with CML was assessed. 24 Thirty-three patients received GI as first-line therapy, and 58 switched from BI to GI after a median of 4.5 years (range: 0.5-13.6). The 12-month progression-free and overall survival rates were 92% and 100%, respectively, and most (85%; n = 144) adverse events were mild.…”

Section: Size and Characterization Of Cohortsmentioning

confidence: 99%

“…However, in a trial conducted in Iraq, the safety profile of GI was shown to be different from that of BI . In addition, several retrospective, nonrandomized studies in adult patients from the developing world in the last year have described a favorable profile of GI . The key results of these studies are summarized in Table .…”

Section: Introductionmentioning

confidence: 99%

“…The authors commented that prospective randomized trials with larger numbers of patients and longer FU periods are needed to address the effect of GI on EMR . In an observational study from Jordan, the efficacy and safety of GI in 91 adult patients with CML was assessed . Thirty‐three patients received GI as first‐line therapy, and 58 switched from BI to GI after a median of 4.5 years (range: 0.5–13.6).…”

Section: Introductionmentioning

confidence: 99%

See 3 more Smart Citations

Generic formulations of imatinib for treatment of Philadelphia chromosome–positive leukemia in pediatric patients

Suttorp¹,

Metzler

Millot³

et al. 2018

Pediatric Blood & Cancer

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Since the patent for imatinib has expired, the role of generic imatinib (GI) in the management of Philadelphia chromosome-positive (Ph+) leukemia in pediatric patients has had ongoing discussion. Some studies in adults demonstrated that equivalent doses of GI and branded imatinib (BI) result in comparable plasma concentrations and clinical efficacy. However, other studies found that GI users are more likely to stop imatinib, with intolerance and decreased persistence as the main causes. Economic factors also heavily influence GI selection. This article aims to review the present knowledge to support further discussion on the role of GI in the management of pediatric Ph+ leukemia.

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Section: Introductionmentioning

confidence: 83%

Section: Size and Characterization Of Cohortsmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

See 2 more Smart Citations

Generic formulations of imatinib for treatment of Philadelphia chromosome–positive leukemia in pediatric patients

Suttorp¹,

Metzler

Millot³

et al. 2018

Pediatric Blood & Cancer

View full text Add to dashboard Cite

show abstract

“…This is an indirect suggestion that a well‐regulated and quality‐controlled generic imatinib can maintain the same efficacy of its original form. Many trials evaluated switching from original to generic imatinib and reported no difference in efficacy and safety between the two forms . Kang et al evaluated 30 patients in Canada who switched to generic imatinib (Apotex‐TEVA) and reported loss of MMR in one patient and loss of CHR in one patient with all other patients maintaining their response.…”

Section: Discussionmentioning

confidence: 99%

Efficacy and safety of generic imatinib after switching from original imatinib in patients treated for chronic myeloid leukemia in the United States

et al. 2019

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Introduction Imatinib is standard therapy for patients with chronic myeloid leukemia (CML). In February 2016, a generic formulation entered the US market. Physicians and patients are frequently concerned about whether switching from original to generic drugs may affect the efficacy and/or safety. Materials and methods This is an observational retrospective study using medical charts of patients diagnosed with CML in the chronic phase who were treated with original imatinib from the year 2000 to 2017 and who were subsequently switched to generic imatinib. Results In this study, 38 patients have switched to generic imatinib. Before the switch, responses were assessed on all patients, all of them were in CCyR and 36 (95%) were in MMR, including 28 (74%) with MR4.5. Patients have received generic imatinib for a median of 19.4 (range, 3.4‐46.3) months. Molecular responses after switching were stable in 89%, improved in 8%, and worsened in 3% of patients. After switching, 15 (39%) patients reported new or worsening adverse events, including 5 (13%) patients with edema, 8 (21%) muscle cramps, 7 (18%) nausea, 6 (16%) diarrhea, and 5 (13%) fatigue. Discussion Bioequivalence studies demonstrated the same rate and extent of absorption of generic imatinib compared to the original form, which led to the FDA approval. In our observational series, most of the patients maintained their responses and none lost MMR. Adverse events noted were mild and well tolerated. Conclusion A change from original to generic imatinib appears to maintain efficacy and be generally safe. More patients and longer follow‐up are required to confirm these observations.

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Switch from branded to generic imatinib: impact on molecular responses and safety in chronic-phase chronic myeloid leukemia patients

et al. 2020

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Generic Imatinib Therapy Among Jordanians: An Observational Assessment of Efficacy and Safety in Routine Clinical Practice

Abstract: This study suggests that the efficacy and safety of generic imatinib in this Middle Eastern population in routine clinical practice are comparable to patented imatinib, and to that of the global population.

Cited by 11 publications

References 19 publications

Generic formulations of imatinib for treatment of Philadelphia chromosome–positive leukemia in pediatric patients

Generic formulations of imatinib for treatment of Philadelphia chromosome–positive leukemia in pediatric patients

Efficacy and safety of generic imatinib after switching from original imatinib in patients treated for chronic myeloid leukemia in the United States

Switch from branded to generic imatinib: impact on molecular responses and safety in chronic-phase chronic myeloid leukemia patients

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