 |
20 Diseases |  |
19 Trials |
|
19 Trials |  |
1670 News |  |
| «12345678910111213...1819» |
- | Biomarker, Trial completion date: NRG-LU003: Targeted Treatment for ALK Positive Patients Who Have Previously Been Treated for Non-squamous Non-small Cell Lung Cancer (clinicaltrials.gov) - Nov 21, 2023
P2, N=10, Active, not recruiting, Sponsor: National Cancer Institute (NCI)
Trial completion date: Apr 2024 --> Sep 2024
- | Zykadia (ceritinib) / Novartis
Journal: The small-molecule kinase inhibitor ceritinib, unlike imatinib, causes a significant disturbance of lipid membrane integrity: A combined experimental and MD study. (Pubmed Central) - Nov 20, 2023
The pronounced membrane impact of ceritinib can be explained by a strong affinity of the drug towards POPC which competes with the POPC-cholesterol interaction by that attenuating the ordering effect of cholesterol. The data are relevant for understanding putative toxic and cytotoxic side effects of these drugs such as the triggering of cell lysis or apoptosis.
- | Zykadia (ceritinib) / Novartis, Mekinist (trametinib) / Novartis, BeiGene
Trial primary completion date: Study of Trametinib + Ceritinib in Patients With Unresectable Melanoma (clinicaltrials.gov) - Nov 15, 2023
P1, N=27, Active, not recruiting, Sponsor: H. Lee Moffitt Cancer Center and Research Institute
The data are relevant for understanding putative toxic and cytotoxic side effects of these drugs such as the triggering of cell lysis or apoptosis. Trial primary completion date: Oct 2023 --> Jan 2023
- || Review, Journal: Update of Diagnosis and Targeted Therapy for ALK Inflammation Myofibroblastic Tumor. (Pubmed Central) - Nov 8, 2023
After the approval of crizotinib, other ALK-TKIs, such as ceritinib, alectinib, brigatinib, and lorlatinib, have proven their efficacy on ALK IMT with sporadic case reports. The sequential treatments of targeted therapies in may provide the insight into the choice of ALK-TKIs in different lines of treatment for unresectable ALK IMT.
- Zykadia (ceritinib) / Novartis, Rozlytrek (entrectinib) / Roche, Alunbrig (brigatinib) / Takeda
Targeting IGF1R/Insr Pathway with Approved ALK-Inhibitors Overcomes Proteasome Inhibitor Resistance in Multiple Myeloma (SDCC - Halls G-H) - Nov 3, 2023 - Abstract #ASH2023ASH_6114;
Ceritinib, an FDA-approved drug, overcomes PI resistance in MM by targeting InsR/IGF1R signaling, which is essential for PI resistance in MM. Therefore, ceritinib represents a promising, potential option for the treatment of PI-resistant MM.
- Lorbrena (lorlatinib) / Pfizer
Preliminary Results of Phase 2 Open Label Study of Lorlatinib Monotherapy in Relapsed/Refractory ALK + Lymphomas Previously Treated with Other Tyrosine Kinase Inhibitors (SDCC - Halls G-H) - Nov 3, 2023 - Abstract #ASH2023ASH_5916;
P2
The obtainment of CR at M1 seems to represent a pivotal prognostic factor. Lorlatinib also offers a promising bridging regimen to salvage ASCT especially for ALK+ BCL patients, with high response rates and no additional toxicities, .
- | Zykadia (ceritinib) / Novartis
Journal: Three Innovative Green and High-Throughput Microwell Spectrophotometric Methods for the Quantitation of Ceritinib, a Potent Drug for the Treatment of ALK-Positive Non-Small Cell Lung Cancer: An Application to the Analysis of Capsules and Drug Uniformity Testing. (Pubmed Central) - Oct 28, 2023
In addition, these methods encompassed the advantage of high-throughput analysis. In conclusion, the three methods are valuable tools for convenient and reliable application in the pharmaceutical quality control units for CER-containing capsules.
- | Zykadia (ceritinib) / Novartis
Journal: Development of Two Novel One-Step and Green Microwell Spectrophotometric Methods for High-Throughput Determination of Ceritinib, a Potent Drug for Treatment of Anaplastic Lymphoma Kinase-Positive Non-Small-Cell Lung Cancer. (Pubmed Central) - Oct 28, 2023
In addition, the simultaneous handling of a large number of samples with microvolumes in the proposed methods gave them the advantage of a high-throughput analysis. The two methods are valuable tools for rapid routine application in pharmaceutical quality control units for the quantitation of CER.
- ||| Zykadia (ceritinib) / Novartis
Trial completion date: ASCEND-4: LDK378 Versus Chemotherapy in Previously Untreated Patients With ALK Rearranged Non-small Cell Lung Cancer (clinicaltrials.gov) - Oct 17, 2023
P3, N=376, Active, not recruiting, Sponsor: Novartis Pharmaceuticals
The two methods are valuable tools for rapid routine application in pharmaceutical quality control units for the quantitation of CER. Trial completion date: Sep 2023 --> Dec 2023
- Comparative cost-effectiveness analysis of oral agents for advanced EGFR mutated and ALK-positive non-small cell lung cancer. (3rd Floor, Back Bay Hall; Poster Bd #: B9) - Oct 13, 2023 - Abstract #ASCOQC2023ASCO_QC_104;
The findings indicate the higher costs of Osimertinib and certain ALK inhibitors, which need to be weighed against the potential improvements in QALYs. By considering both costs and effectiveness, healthcare decision-makers can optimize treatment strategies, allocate resources efficiently and improve patient outcomes.
- ||| Lorbrena (lorlatinib) / Pfizer, Xalkori (crizotinib) / Pfizer, Vizimpro (dacomitinib) / Pfizer
Enrollment open, Metastases: DELINOR: A Study to Learn About the Effectiveness of Cancer Medicines in Patients With Metastatic Non-small Cell Lung Cancer in Norway. (clinicaltrials.gov) - Oct 10, 2023
P=N/A, N=20605, Recruiting, Sponsor: Pfizer
By considering both costs and effectiveness, healthcare decision-makers can optimize treatment strategies, allocate resources efficiently and improve patient outcomes. Not yet recruiting --> Recruiting
- Zykadia (ceritinib) / Novartis, Kisqali (ribociclib) / Novartis, Stivarga (regorafenib) / Bayer
Real-world adverse events of targeted therapy reported by pharmacist in oncology clinic (Exhibition area) - Oct 6, 2023 - Abstract #ESMOAsia2023ESMO_Asia_947;
Rarely severe AEs were reported. Health care providers will need to educate and monitor cancer patients to prevent and monuments AEs during targeted therapy treatment.
- || Review, Journal, PD(L)-1 Biomarker, Metastases: Treatment of advanced ALK-rearranged NSCLC following second-generation ALK-TKI failure. (Pubmed Central) - Sep 29, 2023
In cases of ALK-dependent resistance mutations, lorlatinib could be the first choice as it exhibits the broadest coverage of mutations that lead to resistance against second-generation ALK - TKIs, such as G1202R, and L1196M. In cases of no resistance mutations, atezolizumab, bevacizumab and platinum-based chemotherapy could be the alternative treatment option.
- || Zolinza (vorinostat) / Merck (MSD), Zykadia (ceritinib) / Novartis
Trial completion date, Trial primary completion date, Metastases: PEDS-PLAN: Pediatric Precision Laboratory Advanced Neuroblastoma Therapy (clinicaltrials.gov) - Sep 28, 2023
P2, N=500, Recruiting, Sponsor: Giselle Sholler
In cases of no resistance mutations, atezolizumab, bevacizumab and platinum-based chemotherapy could be the alternative treatment option. Trial completion date: Sep 2032 --> Sep 2035 | Trial primary completion date: Sep 2027 --> Sep 2030
- | Xalkori (crizotinib) / Pfizer, Zykadia (ceritinib) / Novartis, Fotivda (tivozanib) / Kyowa Kirin, Jazz, LG Chem
Journal: Comparative docking analysis of tyrosine kinase inhibitors with HER2 and HER4 receptors. (Pubmed Central) - Sep 1, 2023
Lapatinib is identified as a potential inhibitor for both the RTKs. Our study thus suggests the probable direction that could be further explored in inhibiting EGFR protein harboring breast cancer.
- | Zykadia (ceritinib) / Novartis
Journal: A computational-based approach to fabricate Ceritinib co-amorphous system using a novel co-former Rutin for bioavailability enhancement. (Pubmed Central) - Aug 28, 2023
CRT:RTH 1:1 CAMs improved the permeability of CRT by 2 fold, estimated by employing the everted gut sac method. The solubility advantage of CAMs was also reflected in pharmacokinetic parameters, with a 3.1-fold and 2-fold improvement of CRT:RTH 2:1 in CRT exposure (AUC 0-t) and plasma concentration (Cmax) compared to the physical mixture, respectively.
- Safety and Efficacy of Stereotactic Radiosurgery with Concurrent Targeted Systemic Therapy for Brain Metastases (Hall B2; In Person Only; Screen: 11) - Aug 22, 2023 - Abstract #ASTRO2023ASTRO_663;
Although heterogeneous, patients treated with SRS/SRT and ongoing CNS-active targeted systemic therapies have on average >6 month intracranial PFS and little evidence of significant toxicity. We observed <6% G2+ radiation necrosis for this cohort, and no particular class of agent was associated with a significantly higher rate of G2+ radiation necrosis.
- ||| Zykadia (ceritinib) / Novartis
Trial completion date: ASCEND-4: LDK378 Versus Chemotherapy in Previously Untreated Patients With ALK Rearranged Non-small Cell Lung Cancer (clinicaltrials.gov) - Aug 21, 2023
P3, N=376, Active, not recruiting, Sponsor: Novartis Pharmaceuticals
We observed <6% G2+ radiation necrosis for this cohort, and no particular class of agent was associated with a significantly higher rate of G2+ radiation necrosis. Trial completion date: Jul 2025 --> Sep 2023
- ||| Zykadia (ceritinib) / Novartis
Trial completion date, Metastases: LDK378 Versus Chemotherapy in ALK Rearranged (ALK Positive) Patients Previously Treated With Chemotherapy (Platinum Doublet) and Crizotinib (clinicaltrials.gov) - Aug 16, 2023
P3, N=231, Active, not recruiting, Sponsor: Novartis Pharmaceuticals
Trial completion date: Jul 2025 --> Sep 2023 Trial completion date: Jun 2026 --> Oct 2023
- | Journal: Anaplastic Lymphoma Kinase Inhibitors for Therapy of Neuroblastoma in Adults. (Pubmed Central) - Aug 14, 2023
ALKis, particularly lorlatinib, are effective treatment options for AON. However, AEs necessitating dose reduction are common.
- | Zykadia (ceritinib) / Novartis
Journal: N76-1, a novel CDK7 inhibitor, exhibits potent anti-cancer effects in triple negative breast cancer. (Pubmed Central) - Aug 14, 2023
In this study, we obtained an inhibitor of CDK7, N76-1, by attaching the side chain of the covalent CDK7 inhibitor THZ1 to the core of the anaplastic lymphoma kinase inhibitor ceritinib...Moreover, N76-1 markedly inhibited the growth of TNBC xenografts and phosphorylation of RNAPII in tumor tissues. In summary, N76-1 exerts potent anticancer effects in TNBC by inhibiting CDK7 and provides a new strategy and research basis for the development of new drugs for TNBC.
- ||| Journal, Adverse events, Real-world evidence, Real-world: Interstitial Lung Disease Risk of Anaplastic Lymphoma Kinase Tyrosine Kinase Inhibitor Treatment of Non-small Cell Lung Cancer: A Real-world Pharmacovigilance Study. (Pubmed Central) - Aug 8, 2023
The highest and lowest proportions of ILD-related fatalities were observed after crizotinib and alectinib treatment, respectively. ALK-TKIs were associated with ILD; therefore, the risk of developing ILD after treatment with an ALK-TKI should be carefully considered in clinical settings.
- | Xalkori (crizotinib) / Pfizer, Zykadia (ceritinib) / Novartis
Journal: Activity of ceritinib in crizotinib-resistant ROS1-rearranged non-small-cell lung cancer patients. (Pubmed Central) - Jul 25, 2023
In addition, of the 6 patients with brain metastases, an intracranial disease control rate of 66.7% (95% CI:12.5% to 120.9%) was obtained. The research results reveal that ceritinib can be a treatment option for ROS1-rearranged NSCLC patients after the development of crizotinib resistance.
- Real-World Outcome of Metastatic ALK-Positive Non-Small Cell Lung Cancer Treated with Tyrosine Kinase Inhibitors (Exhibit Hall) - Jul 25, 2023 - Abstract #IASLCWCLC2023IASLC_WCLC_2308;
Patients with advanced ALK-positive NSCLC have prolonged survival after the introduction of ALK TKIs with a median OS that exceeds 5 years when ALK TKIs are used in the first-line setting. Re-biopsies during treatment are needed to enhance our understanding of resistance mechanisms and the tumor dynamics that develop during ALK TKI therapy and to increase individualized management of this disease within precision medicine.
- Mechanisms of Acquired Resistance to ALK Inhibitors Using Plasma Sequencing - Preliminary Data from the ATORG004 Study (Exhibit Hall) - Jul 25, 2023 - Abstract #IASLCWCLC2023IASLC_WCLC_2307;
DDR and cell cycle gene alterations were commonly detected and may represent previously unreported acquired resistance alterations. Comprehensive ctDNA NGS analysis at progression may help detect novel resistance alterations in patients on ALK inhibitors.
- Zykadia (ceritinib) / Novartis, Tagrisso (osimertinib) / AstraZeneca
High-Throughput Screening Reveals Ceritinib as a Sensitizer for Cafs-Induced Osimertinib Resistance in Non-small Cell Lung Cancer (Exhibit Hall) - Jul 25, 2023 - Abstract #IASLCWCLC2023IASLC_WCLC_1250;
Comprehensive ctDNA NGS analysis at progression may help detect novel resistance alterations in patients on ALK inhibitors. Ceritinib can reverse CAFs-induced osimertinib resistance in NSCLC cells by targeting IGF signaling
- || Review, Journal: Importance of ROS1 gene fusions in non-small cell lung cancer. (Pubmed Central) - Jul 17, 2023
There are currently numerous FDA-approved agents for these tumors, including crizotinib and entrectinib; however, there is in-vitro sensitivity data and clinical data documenting responses to ceritinib and lorlatinib...To combat the mechanisms of resistance, novel agents such as repotrectenib, cabozantinib, talotrectinib, and others are being developed. In this article, we examine the literature pertaining to patients with ROS1 tumors, including epidemiology, clinical outcomes, resistance mechanisms, and treatment options.
- || Zykadia (ceritinib) / Novartis, Alecensa (alectinib) / Roche
Buenas, yo hago terapia dirigida desde hace 3 años y medio. Empecé con Alectinib però al año y medio hice resistencia i me canviaron la medicacion i ahora tomo ceritinib. La verdad es que me encuentro muy bien y hace año volví a trabajar. (Twitter) - Jul 8, 2023
- || Review, Journal, Adverse drug reaction: Expert consensus of management of adverse drug reactions with anaplastic lymphoma kinase tyrosine kinase inhibitors. (Pubmed Central) - Jul 3, 2023
The therapeutic use of this class of medications still carries some risk because there are currently no pertinent guidelines or consensus recommendations for managing ADRs caused by ALK-TKIs in China. In order to improve the clinical management of ADRs with ALK-TKIs, the Chinese Society of Clinical Oncology (CSCO) Non-small Cell Lung Cancer Professional Committee led the discussion and summary of the incidence, diagnosis and grading standards, and prevention and treatment of ADRs caused by ALK-TKIs.
- || Biomarker, PK/PD data, Review, Journal, PARP Biomarker: Dose Optimization in Oncology Drug Development: The Emerging Role of Pharmacogenomics, Pharmacokinetics, and Pharmacodynamics. (Pubmed Central) - Jun 28, 2023
The FDA recognized the drawbacks of this approach and, in 2021, launched Project Optimus, which provides the framework and guidance for dose optimization during the clinical development stages of anticancer agents. Since dose optimization is crucial in clinical development, especially of targeted therapies, it is necessary to identify the role of pharmacological tools such as pharmacogenomics, therapeutic drug monitoring, and pharmacodynamics, which could be integrated into all phases of drug development and support dose optimization, as well as the chances of positive clinical outcomes.
- | Zykadia (ceritinib) / Novartis
Biomarker, Trial completion date, Trial primary completion date, Combination therapy, Metastases: Ceritinib and Everolimus in Treating Patients With Locally Advanced or Metastatic Solid Tumors or Stage IIIB-IV Non-small Cell Lung Cancer (clinicaltrials.gov) - Jun 22, 2023
P1, N=37, Active, not recruiting, Sponsor: M.D. Anderson Cancer Center
Since dose optimization is crucial in clinical development, especially of targeted therapies, it is necessary to identify the role of pharmacological tools such as pharmacogenomics, therapeutic drug monitoring, and pharmacodynamics, which could be integrated into all phases of drug development and support dose optimization, as well as the chances of positive clinical outcomes. Trial completion date: Jun 2023 --> Dec 2024 | Trial primary completion date: Jun 2023 --> Dec 2024
- || Lorbrena (lorlatinib) / Pfizer
Preclinical, Review, Journal, Metastases: From preclinical efficacy to 2022 updated CROWN trial, lorlatinib is the preferred 1-line treatment of advanced ALK+ NSCLC. (Pubmed Central) - Jun 12, 2023
Trial completion date: Jun 2023 --> Dec 2024 | Trial primary completion date: Jun 2023 --> Dec 2024 Six ALK TKIs (crizotinib, ceritinib, alectinib, brigatinib, lorlatinib, ensartinib) have received first-line treatment indication of advanced ALK+
- || Review, HEOR, Cost-effectiveness, Cost effectiveness, Metastases: A Systematic Review of the Cost-Effectiveness Analyses of Anaplastic Lymphoma Kinase (ALK) Inhibitors in Patients with Locally Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC). (Pubmed Central) - Jun 3, 2023
The findings summarized available evidence on cost effectiveness of ALK inhibitors for the treatment of patients with locally advanced or metastatic ALK+ NSCLC across lines of treatment settings and generated a valuable overview of analytical approaches utilized to support future economic analyses. To help further inform treatment and policy decisions, this review emphasizes the need for comparative cost effectiveness of multiple ALK inhibitors simultaneously using real-world data sources with broad representation of settings.
- || Clinical, Review, Journal: Sustained Improvement in the Management of Patients with Non-Small-Cell Lung Cancer (NSCLC) Harboring ALK Translocation: Where Are We Running? (Pubmed Central) - May 30, 2023
Several randomized trials have proven that ALK inhibitors (ALK-Is) have greater efficacy with respect to platinum-based chemotherapy and that second/third generation ALK-Is are better than crizotinib in terms of improvements in median progression-free survival and brain metastases management...This review summarizes first-line randomized clinical trials of several ALK-Is and the management of brain metastases with a focus on ALK-I resistance mechanisms. The last section addresses future developments and challenges.
- ||| Journal, Adverse events: Cardiovascular Toxicities Associated with Anaplastic Lymphoma Kinase Inhibitors: A Disproportionality Analysis of the WHO Pharmacovigilance Database (VigiBase). (Pubmed Central) - May 29, 2023
Systematic evaluation of ALK inhibitor-associated adverse events revealed differences in the cardiotoxicity profiles among ALK inhibitors. Understanding the differences in the cardiovascular toxicity profile of each ALK inhibitor will contribute to safe drug therapy when switching between ALK inhibitors.
- | Zykadia (ceritinib) / Novartis
Journal: Discovery of a miniaturized PROTAC with potent activity and high selectivity. (Pubmed Central) - May 29, 2023
AP-1 with an extremely simple PROTAC structure can be served as an effective candidate drug for therapy of various types of ALK-positive cancers. And the design principle of AP-1 has a good guiding significance for overcoming the disadvantages such as excessive molecular weight and poor solubility of PROTAC.
- || Xalkori (crizotinib) / Pfizer, Zykadia (ceritinib) / Novartis
Review, Journal: Targeted Treatment of Soft-Tissue Sarcoma. (Pubmed Central) - May 27, 2023
Many targeted agents can precisely target specific genetic alterations in advanced STS. The MDM2 inhibitor has shown promising results.
- | Zykadia (ceritinib) / Novartis
Journal: ZYY-B-2, a novel ALK inhibitor, overcomes resistance to ceritinib by inhibiting P-gp function and induces apoptosis through mitochondrial pathway in ceritinib-resistant H2228?cells. (Pubmed Central) - May 22, 2023
ZYY-B-2 could inhibit the expression of P-gp in a dose-dependent manner to overcome ceritinib resistance, and the suppression effect of ZYY-B-2 on P-gp might be related to its inhibition of PI3K/AKT signaling pathway. In summary, ZYY-B-2, a promising ALK inhibitor, shows potent activity against ceritinib-resistant cells, which provides experimental and theoretical basis for the further development of new ALK inhibitors.
- || Zykadia (ceritinib) / Novartis
Review, Journal, Metastases: Ceritinib as First-line Treatment for Advanced Lung Adenocarcinoma with COX7A2L-ALK Fusion: A Case Report and Literature Review (Pubmed Central) - May 19, 2023
The objective response rate (ORR) was 82.6% (19/23) and disease control rate (DCR) was 95.7% (22/23) for rare ALK fusions patients treated with ALK inhibitors. Lung adenocarcinoma patients with rare ALK fusion could benefit from ALK inhibitors..
- || Zykadia (ceritinib) / Novartis
Trial completion date, Trial primary completion date, Combination therapy: Study of Safety and Efficacy of Ceritinib in Combination With Nivolumab in Patients With ALK-positive Non-small Cell Lung Cancer (clinicaltrials.gov) - May 19, 2023
P1, N=57, Active, not recruiting, Sponsor: Novartis Pharmaceuticals
Lung adenocarcinoma patients with rare ALK fusion could benefit from ALK inhibitors.. Trial completion date: Oct 2023 --> Apr 2024 | Trial primary completion date: Oct 2023 --> Apr 2024
- Adcetris (brentuximab vedotin) / Seagen, Takeda, Alunbrig (brigatinib) / Takeda
BRIGATINIB IN PATIENTS WITH ALK-POSITIVE ANAPLASTIC LARGE CELL LYMPHOMA WHO HAVE FAILED BRENTUXIMAB VEDOTIN (Poster area) - May 12, 2023 - Abstract #EHA2023EHA_1452;
These results should be confirmed in prospective studies. Relapsed lymphoma, Kinase inhibitor, ALK/ALCL
- | Zykadia (ceritinib) / Novartis
Journal: Neoadjuvant ceritinib treatment achieved pathological complete response in patients with anaplastic lymphoma kinase positive stage IIIA-N2 non-small cell lung cancer. (Pubmed Central) - May 1, 2023
Relapsed lymphoma, Kinase inhibitor, ALK/ALCL No abstract available
- |||||| Lorbrena (lorlatinib) / Pfizer, Xalkori (crizotinib) / Pfizer, Vizimpro (dacomitinib) / Pfizer
New trial, Metastases: DELINOR: A Study to Learn About the Effectiveness of Cancer Medicines in Patients With Metastatic Non-small Cell Lung Cancer in Norway. (clinicaltrials.gov) - Apr 28, 2023
P=N/A, N=20605, Not yet recruiting, Sponsor: Pfizer
- Xalkori (crizotinib) / Pfizer, Zykadia (ceritinib) / Novartis, Alecensa (alectinib) / Roche
Anaplastic lymphoma kinase (ALK) and ROS 1 () - Apr 26, 2023 - Abstract #ASCO2023ASCO_6456;
Majority of patients were never smokers. Opposite lung and bone were the most common site of metastases.
- A real-world study of ALK fusion detection, treatment patterns, and survival outcomes of patients with advanced non () - Apr 26, 2023 - Abstract #ASCO2023ASCO_5866;
Fast access to molecular diagnosis and exposure to ALK TKI in first line are being incentivized. EML4-ALK variant prevalence in Brazilian patients with aNSCLC is different from published cohorts, and the effect that non-canonical variants may have on ALK TKI activity must be studied further.
- Impact of EML4-ALK fusion variant and co-occurring TP53 mutation on treatment duration of first-line next-generation ALK TKIs in ALK fusion+ NSCLC. (On Demand | Hall A; Poster Bd # 17) - Apr 26, 2023 - Abstract #ASCO2023ASCO_3438;
Additional novel or combination therapies are warranted for this subpopulation. >a 117 pts had data for both TP53 and EML4-ALK V1 or V3.
- Zykadia (ceritinib) / Novartis, Iclusig (ponatinib) / Takeda, Otsuka, Incyte, Turalio (pexidartinib) / Daiichi Sankyo
Dosage optimization in drug development: An FDA Project Optimus analysis of postmarketing requirements issued to repair the cracks. (On Demand | Hall A; Poster Bd # 192) - Apr 26, 2023 - Abstract #ASCO2023ASCO_1546;
This process was slow with a median of 6 years to fulfill a PMR. DO in the premarket setting has the potential to rapidly maximize BR, avoiding both patient exposure to unnecessary toxicity and large, resource-intensive, multi-year postmarketing trials.
- Zykadia (ceritinib) / Novartis
Preclinical evidence of a novel mechanism of action and therapeutic potential of ceritinib in cholangiocarcinoma () - Apr 21, 2023 - Abstract #CCF2023CCF_129;
- | Biomarker, Enrollment change, Trial completion date: NRG-LU003: Targeted Treatment for ALK Positive Patients Who Have Previously Been Treated for Non-squamous Non-small Cell Lung Cancer (clinicaltrials.gov) - Apr 14, 2023
P2, N=10, Active, not recruiting, Sponsor: National Cancer Institute (NCI)
DO in the premarket setting has the potential to rapidly maximize BR, avoiding both patient exposure to unnecessary toxicity and large, resource-intensive, multi-year postmarketing trials. N=660 --> 10 | Trial completion date: May 2023 --> Apr 2024
- || Retrospective data, Review, Journal: Efficacy and safety of anaplastic lymphoma kinase inhibitors for non-small cell lung cancer: A systematic review and network meta-analysis. (Pubmed Central) - Apr 4, 2023
N=660 --> 10 | Trial completion date: May 2023 --> Apr 2024 These results indicated that alectinib could be associated with the best therapeutic efficacy and well-tolerance AEs in the treatment of ALK-positive NSCLC.