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- || Retrospective data, Review, Journal: ALK inhibitors in ALK-rearranged non-small cell lung cancer with and without brain metastases: systematic review and network meta-analysis. (Pubmed Central) - Sep 28, 2022
The limited OS follow-up and inadequate sample sizes might contribute to having no statistically significant difference in OS of lorlatinib versus crizotinib. More high-quality and longer follow-up RCTs are warranted to prove our findings.
- | Xalkori (crizotinib) / Pfizer
Enrollment change: EAY131-G: Testing Crizotinib as a Potential Targeted Treatment in Cancers With ROS1 Genetic Changes (MATCH-Subprotocol G) (clinicaltrials.gov) - Sep 28, 2022
P2, N=4, Active, not recruiting, Sponsor: National Cancer Institute (NCI)
More high-quality and longer follow-up RCTs are warranted to prove our findings. N=35 --> 4
- Xalkori (crizotinib) / Pfizer
UNEXPECTED SEVERE TOXICITY OF CRIZOTINIB IN COMBINATION WITH VINBLASTINE: THE CRISP OPEN-LABEL PHASE 1B TRIAL IN PEDIATRIC PATIENTS WITH ANAPLASTIC LARGE CELL LYMPHOMA (ALCL) (ITCC-053) () - Sep 25, 2022 - Abstract #SIOP2022SIOP_691;
P1/2
The unexpected severe toxicity described here is probably due to a stronger than anticipated CYP3A4 interaction, and possible additional pharmacodynamic interactions. This study emphasizes the importance of (pre-)clinical pharmacological evaluation in trials investigating drug combinations.
- ||||| Preclinical: Growing number of active and promising agents for #ROS1 NSCLC. Crizotinib and entrectinib approved. Lorlatinib with some activity. Repotrectinib in development. Preclinical data for NVL-520 (ARROS-1) with quite impressive numbers. Good to see more options here! #NACLC22 #LCSM (Twitter) - Sep 24, 2022
- | Xalkori (crizotinib) / Pfizer
Trial completion date, Trial primary completion date: PROFILE 1013: An Investigational Drug, Crizotinib (PF-02341066), Is Being Studied In Tumors, Except Non-Small Cell Lung Cancer, That Are Positive For Anaplastic Lymphoma Kinase (ALK) (clinicaltrials.gov) - Sep 23, 2022
P1b, N=44, Active, not recruiting, Sponsor: Pfizer
This study emphasizes the importance of (pre-)clinical pharmacological evaluation in trials investigating drug combinations. Trial completion date: Dec 2022 --> Apr 2023 | Trial primary completion date: Dec 2022 --> Apr 2023
- | Xalkori (crizotinib) / Pfizer
Enrollment change: EAY131-F: Testing Crizotinib as a Potential Targeted Treatment in Cancers With ALK Genetic Changes (MATCH-Subprotocol F) (clinicaltrials.gov) - Sep 22, 2022
P2, N=5, Active, not recruiting, Sponsor: National Cancer Institute (NCI)
Trial completion date: Dec 2022 --> Apr 2023 | Trial primary completion date: Dec 2022 --> Apr 2023 N=35 --> 5
- || Xalkori (crizotinib) / Pfizer, Zykadia (ceritinib) / Novartis
Clinical data, Retrospective data, Journal, Next-generation sequencing: Detection of ALK fusion variants by RNA-based NGS and clinical outcome correlation in NSCLC patients treated with ALK-TKI sequences. (Pubmed Central) - Sep 21, 2022
Nevertheless, in V1+ patients a prolonged clinical benefit was observed. Fusion variant identification by NGS technology may add relevant information about rare chromosomal events that could be potentially correlated to worse outcomes.
- | Xalkori (crizotinib) / Pfizer
Journal, IO biomarker: Molecular, clinicopathological characteristics and surgical results of resectable SMARCA4-deficient thoracic tumors. (Pubmed Central) - Sep 21, 2022
Patients with SMARCA4-deficient tumors have a high probability of early recurrence after surgery, except for stage I patients. Immunotherapy seems to be a valuable strategy to treat recurrence.
- || Xalkori (crizotinib) / Pfizer
Clinical, Journal: Adjuvant crizotinib in high-risk uveal melanoma following definitive therapy. (Pubmed Central) - Sep 20, 2022
Analysis of blood extracellular vesicles revealed changes in protein content associated with treatment, raising the possibility of future use as a biomarker. Further investigation of adjuvant treatment options are necessary for this challenging disease.
- ||| Lorbrena (lorlatinib) / Pfizer, Xalkori (crizotinib) / Pfizer
Clinical: From what I understand from these slides, if a patient ROS1 has G2032R mutation, they are likely to be resistant to both crizotinib and lorlatinib? (Twitter) - Sep 20, 2022
- ||| Enrollment change, Trial completion date, Trial primary completion date, Metastases: The Drug Rediscovery Protocol (DRUP Trial) (clinicaltrials.gov) - Sep 19, 2022
P2, N=1550, Recruiting, Sponsor: The Netherlands Cancer Institute
Further investigation of adjuvant treatment options are necessary for this challenging disease. N=950 --> 1550 | Trial completion date: Dec 2022 --> Dec 2027 | Trial primary completion date: Aug 2022 --> Sep 2027
- || Lorbrena (lorlatinib) / Pfizer, Xalkori (crizotinib) / Pfizer
Trial completion, Combination therapy, IO biomarker, Metastases: Study to Evaluate Safety, Efficacy, Pharmacokinetics And Pharmacodynamics Of Avelumab In Combination With Either Crizotinib Or PF-06463922 In Patients With NSCLC. (Javelin Lung 101) (clinicaltrials.gov) - Sep 15, 2022
P1b/2, N=43, Completed, Sponsor: Pfizer
N=950 --> 1550 | Trial completion date: Dec 2022 --> Dec 2027 | Trial primary completion date: Aug 2022 --> Sep 2027 Active, not recruiting --> Completed
- | Zykadia (ceritinib) / Novartis, Alunbrig (brigatinib) / Takeda, Alecensa (alectinib) / Roche
Journal: Efficacy of Brigatinib in Patients With Advanced Anaplastic Lymphoma Kinase-Positive Non-Small Cell Lung Cancer Who Progressed on Alectinib or Ceritinib: ALTA-2 Study. (Pubmed Central) - Sep 14, 2022
P2
In ALTA-2, brigatinib demonstrated limited activity in patients with ALK+ NSCLC post-ceritinib or post-alectinib therapy. Median PFS was longer with brigatinib in patients without baseline detectable plasma ALK fusion.
- | Preclinical, Journal: Tyrosine kinase inhibitors and direct oral anticoagulants: In vitro evaluation of drug-drug interaction mediated by P-Glycoprotein. (Pubmed Central) - Sep 14, 2022
A risk of drug-drug interaction was found in vitro between TKIs and DOACs. In vivo pharmacokinetic studies are needed to ensure the safety of prescribing DOACs in cancer patients on TKI therapy, in order to avoid major, potentially preventable bleeding events.
- Genotypic Characteristics and Resistance Mutations in Advanced ALK+ NSCLC: The ALK-PATHFINDER Study (Ballroom FGH) - Sep 14, 2022 - Abstract #IASLCNACLC2022IASLC_NACLC_88;
Currently, 20 patients with blood sample collected have been enrolled. The recruitment is expected to be completed by September 2023.
- Xalkori (crizotinib) / Pfizer, Alunbrig (brigatinib) / Takeda
Target Lesion Response and Outcomes in Patients Treated with Brigatinib vs Crizotinib in ALTA-1L (Ballroom FGH) - Sep 14, 2022 - Abstract #IASLCNACLC2022IASLC_NACLC_66;
P2, P3
In this exploratory post hoc analysis, brigatinib demonstrated significantly deeper target lesion response vs crizotinib. Patients with >75% shrinkage had significantly reduced risk of a PFS or OS event vs patients with ≤50% target lesion shrinkage.
- | Lorbrena (lorlatinib) / Pfizer
Journal: Pan-HER inhibitors overcome lorlatinib resistance caused by NRG1/HER3 activation in ALK-rearranged lung cancer. (Pubmed Central) - Sep 12, 2022
Pharmacological inhibition of HER3 with pan-HER inhibitors or genetic knockdown of HER3 with siRNA resensitized H3122LR and A925LLR cells to lorlatinib in vitro, indicating that H3122LR and A925LLR acquired resistance by NRG1/HER3 activation. These findings demonstrate that targeting NRG1/HER3 is a potential novel therapeutic option for lorlatinib-resistant ALK-rearranged lung cancer.
- | Xalkori (crizotinib) / Pfizer
Journal: Co-delivery of F7 and crizotinib by thermosensitive liposome for breast cancer treatment. (Pubmed Central) - Sep 10, 2022
Meanwhile, it was shown that the TSL reduced the systemic toxicity of the chemotherapy drug. Therefore, the F7-Cri-TSL may serve as a promising system for temperature triggered breast cancer treatment.
- | Xalkori (crizotinib) / Pfizer
Retrospective data, Journal: Crizotinib in MET Exon 14-Mutated or MET-Amplified in Advanced Disease Non-Small Cell Lung Cancer - A Retrospective, Single Institution Experience. (Pubmed Central) - Sep 10, 2022
We investigated the characteristics of these patient groups in accordance with mutation types and compared median survival between patient groups. Crizotinib was found to be an optimal treatment for NSCLC harboring c-MET exon 14 skipping mutations.
- | Alunbrig (brigatinib) / Takeda
Retrospective data, Journal, Real-world evidence: Real-World Efficacy and Tolerability of Brigatinib in Patients with Non-Small Cell Lung Cancer with Prior ALK-TKIs in the United States. (Pubmed Central) - Sep 10, 2022
Brigatinib appears to be effective and well-tolerated in the real-world ALK+ NSCLC population in the US, showing benefit in patients after a next-generation ALK-TKI. Notably, dose reduction rates appeared markedly less than those seen in trials when most trial-related dose reductions were for asymptomatic laboratory abnormalities.
- | Journal: Development and validation of a novel LC-MS/MS method for simultaneous quantitative determination of tyrosine kinase inhibitors in human plasma. (Pubmed Central) - Sep 10, 2022
Based on the guidelines on bioanalytical methods by the FDA, the validation studies demonstrated that the three analytes were both precise and accurate at four concentration levels, and the coefficient of variation was 88.26 %. We present a simple, rapid, and sensitive method for the simultaneous quantification of ceritinib, osimertinib, and crizotinib in human plasma by LC-MS/MS, which could be used in routine therapeutic drug monitoring.
- | Xalkori (crizotinib) / Pfizer
Journal: Crizotinib attenuates cancer metastasis by inhibiting TGFβ signaling in non-small cell lung cancer cells. (Pubmed Central) - Sep 10, 2022
Our results demonstrate that crizotinib attenuates cancer metastasis by inhibiting TGFβ signaling in NSCLC cells. Therefore, our findings will help to advance our understanding of the anticancer action of crizotinib and provide insight into future clinical investigations.
- |||| Xalkori (crizotinib) / Pfizer
Clinical: 📣 Original Research Article: Adjuvant crizotinib in high-risk #uvealmelanoma following definitive therapy 👨⚕️👩⚕️ Khan S et al Read here 👉 https://t.co/WM9frjEqd4 @Rdcarval #metastasis #skincancer (Twitter) - Sep 9, 2022
- Xalkori (crizotinib) / Pfizer
THE GENOMIC LANDSCAPE OF CLEAR CELL SARCOMA RESEARCH INITIATIVE () - Sep 9, 2022 - Abstract #CTOS2022CTOS_492;
The ESF-UCL-RNOH CCS research effort will provide a comprehensive molecular landscape of CCS, insights into genomic and transcriptional heterogeneity and evolution. These genomics and tissue resources have the potential to advance research for CCS biology and treatment.
- RETROSPECTIVE STUDY OF THE GENETIC PROFILE OF SARCOMAS IN GREECE: A COOPERATIVE PROGRAM BETWEEN THE HELLENIC GROUP OF SARCOMAS AND RARE TUMORS AND NATIONAL NETWORK OF MEDICAL PRECISION IN ONCOLOGY () - Sep 9, 2022 - Abstract #CTOS2022CTOS_453;
Our study confirms the existence of clinically targeted abnormalities in patients with sarcoma. However, their frequency is low and the clinical benefit depends on the type of mutation.
- Xalkori (crizotinib) / Pfizer, Braftovi (encorafenib) / Ono Pharma, Pierre Fabre, Pfizer, Mektovi (binimetinib) / Ono Pharma, Pierre Fabre, Pfizer
MOLECULAR SCREENING OF ADVANCED SARCOMAS THROUGH NEXT-GENERATION SEQUENCING IN A TERTIARY UNIVERSITY HOSPITAL () - Sep 9, 2022 - Abstract #CTOS2022CTOS_367;
Considering the low response rates to standard treatment, the fact that effective therapeutic alternatives are scarce, and the young age of many of these patients, there is an urgent need for the development of novel therapies. A profound understanding of the molecular mechanisms of sarcomagenesis is essential to propel the era of personalized medicine in advanced sarcomas.
- Xalkori (crizotinib) / Pfizer
EPITHELIOID INFLAMMATORY MYOFIBROBLASTIC SARCOMA WITH LEUKEMOID REACTION () - Sep 9, 2022 - Abstract #CTOS2022CTOS_292;
Since ALK rearrangement presents in all EIMS, the combination therapy of surgical resection and crizotinib or other targeted drugs may be a potential treatment. Disease understanding and study of EIMS among pathologists and clinicians need to be strengthened to improve prognosis of this disease.
- || Xalkori (crizotinib) / Pfizer
Trial completion date: AcS (clinicaltrials.gov) - Sep 8, 2022
P2, N=246, Active, not recruiting, Sponsor: UNICANCER
Disease understanding and study of EIMS among pathologists and clinicians need to be strengthened to improve prognosis of this disease. Trial completion date: Jul 2022 --> Jan 2023
- || Review, Journal: Radiation therapy and targeted therapies: Risks and opportunities (Pubmed Central) - Sep 7, 2022
Trial completion date: Jul 2022 --> Jan 2023 This review provides a point of view in the current state of knowledge, and its limitations highlight the need for more solid data in a field full of promise.
- || Xalkori (crizotinib) / Pfizer, Alunbrig (brigatinib) / Takeda
P1/2 data, P2 data, Journal: Long-Term Efficacy and Safety of Brigatinib in Crizotinib-Refractory ALK+ NSCLC: Final Results of the Phase 1/2 and Randomized Phase 2 (ALTA) Trials. (Pubmed Central) - Sep 7, 2022
Median intracranial PFS for patients with any brain metastases was 12.8 (9.2-18.4) months in arm A and 18.4 (12.6-23.9) months in arm B. No new safety signals were identified versus previous analyses. Brigatinib exhibited sustained long-term activity and PFS with manageable safety in patients with crizotinib-refractory ALK+ NSCLC.
- ||| Xalkori (crizotinib) / Pfizer
Clinical: Understood & agree re- Canada: One country. I was speaking global, but even Canada withheld crizotinib for a long time. Begs the question of whether we really need a randomized trial against outdated SOC when new drug hits a grand slam home run, to use baseball analogy. Think RET (Twitter) - Sep 5, 2022
- Lorbrena (lorlatinib) / Pfizer, NVL-655 / Nuvalent
Preclinical activity of NVL-655 in patient-derived models of ALK cancers, including those with lorlatinib-resistant G1202R/L1196M compound mutation (Exhibition Hall) - Sep 3, 2022 - Abstract #AACRNCIEORTC2022AACR_NCI_EORTC_354;
NVL-655 showed activity in diverse patient-derived models of ALK-positive cancers, including ones that exhibited clinical resistance to prior-generation ALK TKIs. The broad preclinical activity of NVL-655 suggests potential utility as a best-in-class therapy for ALK-positive cancer patients.
- NVL-520 / Nuvalent
Safety and preliminary clinical activity of NVL-520, a highly selective ROS1 inhibitor, in patients with advanced ROS1 fusion-positive solid tumors (Room 111 + 112) - Sep 3, 2022 - Abstract #AACRNCIEORTC2022AACR_NCI_EORTC_156;
P1/2
NVL-520 has been well-tolerated up to 100 mg daily with favorable pharmacokinetics. Activity has been demonstrated in heavily pretreated patients (of whom 70% received ≥2 prior ROS1 TKIs plus chemotherapy), including those with brain metastases and the G2032R mutation.
- || Review, Journal: Anti-Angiogenic Therapy in ALK Rearranged Non-Small Cell Lung Cancer (NSCLC). (Pubmed Central) - Sep 3, 2022
The role for anti-angiogenic therapy in ALK rearranged NSCLC, however, remains to be elucidated. This review will discuss the pre-clinical rationale, clinical trial evidence to date, and future directions to evaluate anti-angiogenic therapy in ALK rearranged NSCLC.
- | Alecensa (alectinib) / Roche
Journal: The percentage of ALK-positive cells and the efficacy of first-line alectinib in advanced non-small cell lung cancer: is it a novel factor for stratification? (Turkish Oncology Group Study). (Pubmed Central) - Sep 2, 2022
Our study demonstrated that the efficacy of alectinib varies significantly across patient subgroups with different percentages of ALK-positive cells. If these findings are prospectively validated, the percentage of ALK-positive cells may be used as a stratification factor in randomized trials comparing different ALK-TKIs.
- A Bayesian Network Meta-Analysis of the Tyrosine Kinase Inhibitors (TKI) for ALK-Positive Advanced Non-Small Cell Lung Cancer With or Without Brain Metastasis (Virtual) - Sep 1, 2022 - Abstract #ISPOREU2022ISPOR_EU_2577;
If these findings are prospectively validated, the percentage of ALK-positive cells may be used as a stratification factor in randomized trials comparing different ALK-TKIs. Lorlatinib showed better estimates of efficacy in comparison to the first and second generation TKIs especially in PFS, with its ranking by the front, which can be considered as the best option for clinical treatment.
- Understanding Treatment Patterns, Disruptions and Potential Limitations of Tyrosine Kinase Inhibitors in ROS1+ Non-Small Cell Lung Cancer Patients in a Retrospective Review of United States Medical Transcription Records (In-person; Virtual) - Sep 1, 2022 - Abstract #ISPOREU2022ISPOR_EU_1955;
Time on TKI therapy varied considerably with majority of patients experiencing early treatment disruptions. Results suggest possible unmet need among ROS1+ NSCLC patients using contemporary TKIs since treatment disruptions can occur within 3 months of initiation, use may be sporadic, and many patients experience disease progression and tolerability issues.
- Healthcare Resource Utilization (HCRU) of United States ROS1+ Non-Small Cell Lung Cancer (NSCLC) Patients Treated With Tyrosine Kinase Inhibitors (TKIs): Analysis of Electronic Medical Transcription Records (In-person; Virtual) - Sep 1, 2022 - Abstract #ISPOREU2022ISPOR_EU_1652;
Most common major events were referrals to specialist, unscheduled visit to ER/clinic, and admittance to hospital. As ROS1+ NSCLC patients are routinely managed, unexpected HCRU events from their current TKIs may be common, and add to the overall economic burden of this condition.
- Xalkori (crizotinib) / Pfizer
Demonstrating Internal and External Validity in Real-World Datasets: A Case Study in MET Exon 14 (METex14) Skipping Non-Small Cell Lung Cancer (NSCLC) (In-person; Virtual) - Sep 1, 2022 - Abstract #ISPOREU2022ISPOR_EU_1202;
Pooling of data allows for better estimation of outcomes despite small sample sizes in individual datasets, though with concerns regarding heterogeneity. Where typical measures of heterogeneity (such as I2) are unavailable, alternative approaches (such as ‘leave one out’ analysis) can be used to demonstrate the internal consistency and external validity of real-world comparator datasets, before using the pooled dataset to perform indirect comparisons with novel interventions.
- Xalkori (crizotinib) / Pfizer
Trial completion date, Trial primary completion date, Metastases: Long Term Safety Observation of Crizotinib in Chinese NSCLC Population (clinicaltrials.gov) - Sep 1, 2022
P4, N=41, Active, not recruiting, Sponsor: Pfizer
Where typical measures of heterogeneity (such as I2) are unavailable, alternative approaches (such as ‘leave one out’ analysis) can be used to demonstrate the internal consistency and external validity of real-world comparator datasets, before using the pooled dataset to perform indirect comparisons with novel interventions. Trial completion date: Dec 2026 --> Jun 2023 | Trial primary completion date: Dec 2026 --> Jun 2023
- ||| Xalkori (crizotinib) / Pfizer, Alecensa (alectinib) / Roche
P3 data, Journal: Final overall survival analysis from the phase III J-ALEX study of alectinib versus crizotinib in ALK inhibitor-naïve Japanese patients with ALK-positive non-small-cell lung cancer. (Pubmed Central) - Aug 31, 2022
Final OS analysis from J-ALEX did not show superiority of alectinib to crizotinib; this result was most likely confounded by treatment crossover. Alectinib remains a standard of care for the treatment of patients with advanced ALK-positive NSCLC.
- | Alunbrig (brigatinib) / Takeda
Journal, HEOR: The cost-effectiveness of brigatinib in adult patients with ALK inhibitor-naive ALK-positive non-small cell lung cancer from a US perspective. (Pubmed Central) - Aug 31, 2022
Work by Source Health Economics was funded by ARIAD Pharmaceuticals, Inc. Professional medical writing assistance was provided by Phillipa White, of Source Health Economics, and funded by ARIAD Pharmaceuticals, Inc.
- ||| Lorbrena (lorlatinib) / Pfizer
Journal, Adverse events: Chinese Expert Consensus on Management of Special Adverse Effects Associated with Lorlatinib (Pubmed Central) - Aug 31, 2022
For advanced NSCLC with ALK positivity, patients should be evaluated for baseline characteristics and pre-existing medication, informed of the potential toxicities, and periodically monitored to balance benefits and risks. Moreover, a multidisciplinary group of experts is essential to establish a comprehensive diagnostic and therapeutic strategy..
- ||| Xalkori (crizotinib) / Pfizer, Alunbrig (brigatinib) / Takeda
P3 data, Journal: Efficacy and Safety of Brigatinib Compared With Crizotinib in Asian vs. Non-Asian Patients With Locally Advanced or Metastatic ALK-Inhibitor-Naive ALK+ Non-Small Cell Lung Cancer: Final Results From the Phase III ALTA-1L Study. (Pubmed Central) - Aug 31, 2022
Efficacy with brigatinib was consistently better than with crizotinib in Asian and non-Asian patients with locally advanced or metastatic ALK inhibitor-naive ALK-+ NSCLC. There were no clinically notable differences in overall safety in Asian vs. non-Asian patients.
- || Clinical, Retrospective data, Journal: Front-line treatment for advanced non-small-cell lung cancer and ALK fusion: a network meta-analysis. (Pubmed Central) - Aug 30, 2022
Lorlatinib may have advantageous PFS compared with other agents but a greater risk of severe toxicity. Second-generation inhibitors, including alectinib, brigatinib, and ensartinib, provide major efficacy with less toxicity and remain appropriate regimens in the front-line setting.
- || Xalkori (crizotinib) / Pfizer
Clinical, Review: Locally Advanced Inflammatory Myofibroblastic Tumor Treated With Targeted Therapy: A Case Report and Literature Review. (Pubmed Central) - Aug 30, 2022
This case report describes a patient with an ALK-rearranged locally advanced pulmonary IMT who was treated with neoadjuvant-intent crizotinib...It is difficult to determine the duration and sequencing of TKI use in these settings as there is little published data to guide decisions. This report also includes a comprehensive compilation of published IMT cases with molecular alterations treated with systemic therapy, which also highlighted the duration of therapies and clinical outcomes.
- | Xalkori (crizotinib) / Pfizer
Journal, PD(L)-1 Biomarker, IO biomarker: Various impacts of driver mutations on the PD-L1 expression of NSCLC. (Pubmed Central) - Aug 28, 2022
In conclusion, individual driver mutations had various impacts on the PD-L1 expression of NSCLC patients. The prognostic role of PD-L1 may also be divergent amongst patients harboring different driver mutations.
- | Zykadia (ceritinib) / Novartis
Journal: Pulmonary granulomatous inflammation after ceritinib treatment in advanced ALK-rearranged pulmonary adenocarcinoma. (Pubmed Central) - Aug 26, 2022
However, biopsies of the pulmonary nodules revealed features of granulomatous inflammation without definite cancer cells. We documented for the first time that ceritinib might be associated with pulmonary granulomatous inflammation, and clinicians should be alert to the possibility that the rare adverse event emerged during ceritinib treatment.
- ||| Xalkori (crizotinib) / Pfizer
Journal, Adverse events: Anaplastic lymphoma kinase tyrosine kinase inhibitors associated gastrointestinal obstruction, perforation, and ulceration: an analysis of the FDA adverse event reporting system database (FAERS). (Pubmed Central) - Aug 24, 2022
The signal of GI ulceration was detected only in crizotinib [ROR 1.23 (1.01-1.50); IC 0.29 (0.01-1.51)]. A statistically significant ROR and IC emerged for the site of the esophagus. CONCLUSION : Overall, the pharmacovigilance study of the FAERS indicates slightly increased reporting of GI obstruction and perforation, which may cause severe or even fatal outcomes among ALK-TKIs users.
- || Xalkori (crizotinib) / Pfizer, Zykadia (ceritinib) / Novartis, Alunbrig (brigatinib) / Takeda
P4 data, Review, Journal: Photosensitivity associated with anaplastic lymphoma kinase inhibitors: a review of postmarketing cases reported to FDA and published in the literature. (Pubmed Central) - Aug 24, 2022
A statistically significant ROR and IC emerged for the site of the esophagus. CONCLUSION : Overall, the pharmacovigilance study of the FAERS indicates slightly increased reporting of GI obstruction and perforation, which may cause severe or even fatal outcomes among ALK-TKIs users. No abstract available