Gefitinib
- Generic Name
- Gefitinib
- Brand Names
- Iressa, Gefitinib Mylan
- Drug Type
- Small Molecule
- Chemical Formula
- C22H24ClFN4O3
- CAS Number
- 184475-35-2
- Unique Ingredient Identifier
- S65743JHBS
- Background
Gefitinib (originally coded ZD1839) is a drug used in the treatment of certain types of cancer. Acting in a similar manner to erlotinib (marketed as Tarceva), gefitinib selectively targets the mutant proteins in malignant cells. It is marketed by AstraZeneca under the trade name Iressa.
- Indication
For the continued treatment of patients with locally advanced or metastatic non-small cell lung cancer after failure of either platinum-based or docetaxel chemotherapies.
- Associated Conditions
- Metastatic Non-Small Cell Lung Cancer
Molecular Profiling Revolutionizes Cancer Treatment: AI and Precision Medicine Shape Future of Oncology
• Molecular oncology has transformed cancer treatment by enabling precise identification of genetic mutations, leading to targeted therapies that have significantly improved survival rates in various cancers.
• Next-generation sequencing and liquid biopsies have emerged as powerful diagnostic tools, allowing non-invasive monitoring of tumor progression and treatment response through ctDNA analysis.
• Artificial Intelligence is revolutionizing molecular oncology by accelerating therapeutic target identification, streamlining drug discovery, and enabling more accurate prediction of treatment responses.
J&J's Carvykti Shows Promise in Earlier Myeloma Treatment
• The CARTITUDE-4 study indicates that Carvykti (ciltacabtagene autoleucel) significantly improves progression-free survival in multiple myeloma patients with 1-3 prior lines of therapy.
• Carvykti, a BCMA-directed CAR-T therapy, may soon be used earlier in the treatment pathway, potentially leapfrogging Bristol-Myers Squibb's Abecma.
• The study compared Carvykti to standard three-drug regimens, showing a significant benefit that led to unblinding of the trial.
• Expansion of Carvykti's use is a key component of J&J's strategy in multiple myeloma, alongside other therapies like Darzalex and bispecific antibodies.
AstraZeneca and Daiichi Sankyo Withdraw EU Application for Lung Cancer Drug Datopotamab Deruxtecan
• AstraZeneca and Daiichi Sankyo withdrew their EU marketing application for datopotamab deruxtecan (Dato-DXd) for advanced non-small cell lung cancer following EMA feedback.
• The decision was based on the Phase III TROPION-Lung01 trial results, where Dato-DXd showed improved PFS but not statistically significant overall survival.
• The companies remain committed to developing Dato-DXd for lung cancer, with ongoing trials exploring its potential in various settings.
• A separate application for Dato-DXd for HER2-negative metastatic breast cancer remains under review by the EMA.
Tagrisso Approved in EU for Unresectable EGFR-Mutated Non-Small Cell Lung Cancer
• AstraZeneca's Tagrisso (osimertinib) gains EU approval for treating unresectable EGFR-mutated non-small cell lung cancer (NSCLC) in adults after platinum-based chemoradiation therapy.
• The approval is based on the Phase III LAURA trial, demonstrating an 84% reduction in disease progression or death risk compared to placebo, with a median PFS of 39.1 months.
• Tagrisso is now the first and only EGFR inhibitor approved in the EU for this specific NSCLC patient population, establishing a new standard of care.
• This approval marks the fifth major authorization based on the LAURA trial, with ongoing regulatory reviews in China, Japan, and other countries.
Durvalumab Gains Priority Review for Muscle-Invasive Bladder Cancer Treatment
• The FDA has granted priority review to durvalumab (Imfinzi) for muscle-invasive bladder cancer (MIBC), potentially expediting its approval.
• Phase 3 NIAGARA trial data supports the application, showing a 32% reduction in disease progression or recurrence with perioperative durvalumab.
• The Imfinzi regimen also demonstrated a 25% reduction in the risk of death, offering a significant survival benefit.
• Regulatory decisions are anticipated in the second quarter of 2025, with potential implications for MIBC treatment standards.
Imfinzi Approved for Limited-Stage Small Cell Lung Cancer, Redefining Treatment
• The FDA has approved AstraZeneca's Imfinzi (durvalumab) for treating adults with limited-stage small cell lung cancer (LS-SCLC) after platinum-based chemotherapy and radiation therapy.
• The approval was based on the ADRIATIC Phase III trial, which showed a 27% reduction in the risk of death compared to placebo, marking a significant breakthrough.
• Median overall survival improved to 55.9 months with Imfinzi versus 33.4 months with placebo, establishing a new benchmark for LS-SCLC treatment.
• Imfinzi is now the only immunotherapy approved for both limited and extensive-stage small cell lung cancer, underscoring its potential to improve survival rates.
Tagrisso Recommended for EU Approval in Unresectable EGFR-Mutated NSCLC
• The CHMP has recommended Tagrisso (osimertinib) for EU approval in patients with unresectable Stage III EGFR-mutated NSCLC after platinum-based chemoradiotherapy.
• The recommendation is based on the LAURA Phase III trial, which demonstrated a significant improvement in progression-free survival with Tagrisso.
• Tagrisso, a third-generation EGFR-TKI, has shown clinical activity against CNS metastases and is already used in earlier and later stages of EGFR-mutated NSCLC.
• This approval aims to address the unmet need for effective treatments in this specific lung cancer patient population, potentially improving outcomes.
FDA Filing for Datopotamab Deruxtecan in EGFR-Mutated NSCLC
• AstraZeneca and Daiichi Sankyo submitted a BLA to the FDA for accelerated approval of datopotamab deruxtecan in EGFR-mutated NSCLC.
• The submission is based on Phase II TROPION-Lung05 trial data and supported by Phase III TROPION-Lung01 and Phase I TROPION-PanTumor01 trials.
• The companies voluntarily withdrew a previous BLA for nonsquamous NSCLC following FDA feedback.
• Datopotamab deruxtecan, a TROP2-directed antibody-drug conjugate, could offer renewed hope for patients with this challenging disease.
Strategies Emerge to Combat Acquired Resistance in EGFR-Mutant NSCLC
• Acquired resistance to osimertinib in EGFR-mutant NSCLC is common, necessitating identification of resistance mechanisms through biopsy.
• Amivantamab, a bispecific antibody targeting EGFR and MET, has shown promise in combination with chemotherapy for patients progressing on EGFR inhibitors.
• Antibody-drug conjugates like patritumab deruxtecan (HER3-DXd) and datopotamab deruxtecan (Dato-DXd) are under investigation to overcome resistance.
• The ORCHARD trial is evaluating various agents combined with osimertinib based on identified TKI resistance mechanisms to optimize treatment strategies.
Tagrisso Approved for Unresectable Stage III EGFR-Mutated NSCLC
• The FDA has approved Tagrisso (osimertinib) for adults with unresectable Stage III EGFR-mutated non-small cell lung cancer (NSCLC) after platinum-based chemoradiation therapy.
• The approval was based on the LAURA Phase III trial, which showed Tagrisso significantly improved progression-free survival compared to placebo.
• Tagrisso reduced the risk of disease progression or death by 84%, offering a new targeted therapy option for patients with these specific mutations.
• This approval expands Tagrisso's use across all stages of EGFR-mutated NSCLC, addressing a critical unmet need for targeted treatments.
Datopotamab Deruxtecan Shows Promise in Advanced Non-Small Cell Lung Cancer
• Datopotamab deruxtecan shows a clinically meaningful trend in improving overall survival for advanced nonsquamous non-small cell lung cancer patients who have received prior therapy.
• In nonsquamous NSCLC patients, datopotamab deruxtecan improved overall survival by 2.3 months compared to docetaxel, regardless of actionable genomic alterations.
• NeoCOAST-2 trial results show datopotamab deruxtecan plus IMFINZI and chemotherapy demonstrating promising response rates in early-stage resectable NSCLC patients.
• AstraZeneca and Roche Tissue Diagnostics are collaborating to co-develop a TROP2-QCS biomarker companion diagnostic to identify patients most likely to benefit from datopotamab deruxtecan.
Barriers to Personalized Medicine: Payer Reimbursement Challenges Slow Diagnostic Test Adoption
• Less than 5% of US private companies currently reimburse for genetic tests, creating a significant barrier to personalized medicine adoption despite its potential to reduce healthcare costs.
• Studies show personalized medicine diagnostic tests can generate savings between $600-$28,000 per patient, with successful examples like Oncotype DX demonstrating $1,930 savings per patient through reduced chemotherapy needs.
• Pay-for-performance models are emerging as a potential solution, growing at 26% annually in the US, offering a win-win approach for pharmaceutical companies and payers in personalized medicine implementation.
Drug Development Updates
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