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Old 01-15-2013, 11:30 AM
Dross Dross is offline
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Default U.S. FDA Grants Priority Review to Boehringer Ingelheim's Afatinib NDA for EGFR Mutat

U.S. FDA Grants Priority Review to Boehringer Ingelheim's Afatinib NDA for EGFR Mutation-Positive Advanced NSCLC

Boehringer Ingelheim Pharmaceuticals Inc. (BIPI) today announced that the New Drug Application (NDA) for its investigational oncology compound afatinib has been accepted for filing and granted Priority Review by the U.S. Food and Drug Administration (FDA). The application for afatinib is currently under review for the treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with an epidermal growth factor receptor (EGFR) mutation as detected by an FDA-approved test. Under the Prescription Drug User Fee Act (PDUFA), the FDA goal for reviewing a drug with Priority Review status is six months from the NDA filing acceptance date. The FDA target action date for afatinib will be in the third quarter of 2013.

Recently, afatinib was also granted orphan drug designation – a status given to a product intended for the treatment of a rare disease or condition. In the United States, orphan drug status provides for seven years of market exclusivity for the orphan drug indication following FDA approval.2 Currently there are no therapies specifically approved by the FDA for patients with locally advanced or metastatic NSCLC with an EGFR mutation.

"The NDA filing of afatinib represents Boehringer Ingelheim's commitment to addressing the significant need that exists for patients with EGFR mutation-positive advanced non-small cell lung cancer," said Sabine Luik, M.D., senior vice president, Medicine & Regulatory Affairs, U.S. Regional Medical Director, Boehringer Ingelheim Pharmaceuticals, Inc. "We are pleased that the FDA has accepted the afatinib application under Priority Review and look forward to working with the agency in the coming months."

The NDA submission for afatinib is supported by Boehringer Ingelheim's comprehensive LUX-Lung clinical trial program, including LUX-Lung 3, the largest Phase III trial conducted to date in first-line EGFR mutation-positive, locally advanced or metastatic NSCLC patients.

"This is an exciting milestone for Boehringer Ingelheim, as this marks our first oncology compound to be submitted for FDA review in the United States," said Kevin Lokay, vice president and business unit head, Oncology, Boehringer Ingelheim Pharmaceuticals, Inc. "Based on the acceptance of the afatinib application, along with our developing oncology pipeline, we are moving forward with our plans to establish a world-class oncology commercial organization."

To facilitate the rapid identification of EGFR mutations, Boehringer Ingelheim is partnering with QIAGEN – a leading global provider of sample and assay technologies – to develop a companion diagnostic for afatinib.

About Afatinib

Afatinib is an investigational, oral, once-daily irreversible ErbB Family Blocker that specifically inhibits epidermal growth factor receptor (EGFR or ErbB1), human epidermal receptor 2 (HER2 or ErbB2) and ErbB4.3 It is currently in Phase III clinical development in advanced NSCLC, head and neck and breast cancer. Afatinib is not approved by the FDA; its safety and efficacy have not been established.

In Europe, Boehringer Ingelheim announced submission of a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) seeking approval of afatinib as a treatment for patients with EGFR (ErbB1) mutation-positive NSCLC in September 2012.

Last edited by gdpawel : 01-15-2013 at 03:07 PM. Reason: posted full article
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Old 01-15-2013, 03:04 PM
gdpawel gdpawel is offline
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Default Dacomitinib Bests Erlotinib (Tarceva) in Advanced Non–Small Cell Lung Cancer

Investigators are reporting improved progression-free survival (PFS) after treatment with the investigational agent dacomitinib compared with erlotinib in patients with non–small cell lung cancer (NSCLC) experiencing progression during chemotherapy.

Erlotinib, which targets a single member of the HER family, inhibits signaling through competitive, reversible binding at the EGFR tyrosine kinase domain. The pan-HER inhibitor dacomitinib binds irreversibly to the adenosine triphosphate domain of all three kinase-active members of the HER family: EGFR, HER2, and HER4.

Suresh S. Ramalingam, MD, chief of the Thoracic Oncology Division at Emory University in Atlanta, Georgia, and coworkers randomized 188 patients to receive either 45 mg of oral dacomitinib or 150 mg of oral erlotinib once daily. In addition to having had no prior HER-directed therapy, patients enrolled in the phase II study had an ECOG performance status of 0 to 2 and had received one or two prior chemotherapy regimens. The primary endpoint of the study was PFS.

The study found that the median PFS w as 2.86 months in the dacomitinib arm versus 1.91 months in the erlotinib group (hazard ratio [HR] = 0.66; 95% CI, 0.47- 0.91; two-sided P = .012).

An improvement in PFS was noted in most clinical and molecular subgroups (Table). In patients with KRAS wild-type tumors, the median PFS was 3.71 months and 1.91 months for the dacomitinib and erlotinib treatment arms, respectively (HR = 0.55; 95% CI, 0.35-0.85; two-sided P = .006). Patients with KRAS wild-type/EGFR wild-type tumors receiving dacomitinib had a median PFS of 2.21 months compared with 1.84 months for patients treated with erlotinib (HR = 0.61; 95% CI, 0.37-0.99; two-sided P = .043).

Median overall survival was similar in the dacomitinib and erlotinib groups: 9.53 months in patients treated with dacomitinib and 7.44 months in patients who received erlotinib (HR = 0.80; 95% CI, 0.56-1.13; two-sided P = .205).

Treatment-related adverse events were more common with dacomitinib, primarily grade 1 and 2, and frequently involved skin and gastrointestinal events.

“The results documented here for dacomitinib suggest that irreversible pan-HER inhibition may offer a new treatment option for patients with advanced NSCLC, potentially representing an effective alternative to reversible inhibition of EGFR,” Ramalingam et al wrote.

The researchers suggested that the superior outcomes with dacomitinib might be due to its mechanism of action, “which potentially includes more complete inhibition of HER signaling by receptor homoand heterodimerization through targeting of all three kinase-active HER receptors and permanent blockade of signaling by covalent receptor modification.”

Ramalingam SS, Blackhall F, Krzakowski M, et al. Randomized phase II study of dacomitinib (PF-00299804), an irreversible pan-human epidermal growth factor receptor inhibitor, versus erlotinib in patients with advanced non-small-cell lung cancer. J Clin Oncol. 2012;30(27):3337-3344.

[url]http://cancerfocus.org/forum/showthread.php?t=842

While Tarceva "reversibly" binds to EGFR (Her1), Afatinib "irreversibly" binds to EGFR (Her1) and EGFR type 2 (Her2), preventing their activation and hopefully inhibiting the unwanted signaling pathways. While Dacomitinib binds irreversibly to the domains of all three kinase-active members of EGFR (Her1), EGFR type 2 (Her2) and EGFR type 4 (Her4).

However, the AngioRx Assay for anti-angiogenic agents has assessed previously unanticipated direct and potentiating anti-angiogenic effects of targeted therapy drugs such as Tarceva (and Iressa) at the tyrosine kinase level.
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Old 01-18-2013, 09:25 AM
gdpawel gdpawel is offline
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Default FDA fast tracks two new lung cancer drugs

(PM Live) - The US FDA has fast-tracked two personalised non-small cell lung cancer (NSCLC) drugs from Boehringer Ingelheim and Roche/Astellas, putting the products on track for approval in the third quarter of this year.

Boehringer was granted priority review for its epidermal growth factor receptor (EGFR) inhibitor afatinib in NSCLC patients with locally advanced or metastatic disease who test positive for the EGFR mutation.

Between 10 and 25 per cent of Caucasian NSCLC patients are EGFR-positive, with the proportion rising to 30-40 per cent in some Asian populations.

The marketing application is based on the results of the phase III LUX-Lung 3 trial, which found that afatinib was able to increase progression-free survival by 11.1 months, significantly better than the 6.9-month increase achieved with Lilly's Alimta (pemetrexed) and cisplatin, which is currently considered the best-in-class therapy.

Boehringer filed for approval of afatinib for the NSCLC indication in Europe last August, and is also carrying out phase III trials of the drug in breast cancer and head and neck cancer.

Meanwhile, Roche and Astellas have been given a fast-track review for their EGFR inhibitor Tarceva (erlotinib) in first-line NSCLC, an indication for which it was approved in Europe in 2011. Once again approval is being sought to use the drug in patents with locally advanced or metastatic NSCLC who are EGFR-positive.

Tarceva's application comes on the back of the EURTAC trial, which found that Tarceva achieved a median PFS of 10.4 months while patients treated with two-drug combinations based on platinum drugs (cisplatin plus docetaxel, cisplatin plus gemcitabine, docetaxel plus carboplatin or gemcitabine plus carboplatin) achieved a PFS of 5.1 months.

The drug, which has been approved for second-line use in NSCLC for some time, has also been shown to be effective as a first-line therapy in the OPTIMAL study, which focused on Asian NSCLC patients.

The EGFR inhibitors as a class are credited with transforming the treatment of NSCLC, but do have a problem with side effects, particularly rash, and the development of resistance.

Afatinib is a slightly different member of the class in that its actions on EGFR are irreversible, which hypothetically means that it could be less prone to activity loss over time.
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  #4  
Old 01-22-2013, 12:53 PM
gdpawel gdpawel is offline
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Default EGF Receptor Tyrosine Kinase Inhibitors

The EGF receptor (EGFR) tyrosine kinase inhibitors (TKIs) Iressa (gefitinib) and Tarceva (erlotinib) have been included in standard treatments for advanced NSCLC. EGFR works through two different downstream signaling pathways, which are activated by the phosphorylation of the ATP-binding domain of the receptor: the MAPK cascade, which activates different genes linked to cell proliferation and survival; and the PI3K–AKT cascade, in which phosphorylated AKT inactivates proapoptotic proteins.

TKIs inhibit the phosphorylation and tyrosine kinase activity of the intracellular domain of EGFR through competitive binding to this site, thus preventing the activation of downstream signaling.

Tarceva (erlotinib), a small molecule (MW: 394 Da), has been approved for second- or third-line advanced NSCLC treatment thanks to the results reported in the BR.21 study (1), which found that, with respect to placebo, it prolonged overall survival (OS) in heavily pretreated patients.

Iressa (gefitinib), another small molecule (MW: 446 Da) that is very similar to Tarceva in terms of mechanism of action, was found to have significant anti-tumoral activity in patients with advanced NSCLC in two Phase II studies (IDEAL-1 and -2) (2,3), but its approval as a treatment for NSCLC was obtained following the IPASS trial (4), in which Iressa was compared with carboplatin–paclitaxel chemotherapy in previously untreated stage IV patients selected on the basis of clinical and histological features, such as female gender, nonsmoker history and adenocarcinoma histology.

In this trial, Iressa proved to be more effective than chemotherapy in prolonging progression-free survival (PFS) in the intention-to-treat population. In a subgroup of patients with activating EGFR mutations (exon 19 or exon 21), a 70% response rate was achieved, and the PFS and OS were longer than that following chemotherapy. Thanks to these encouraging findings, Iressa gained approval in the treatment of patients harboring EGFR mutations, also as first-line therapy.

EGFR TKIs are usually well tolerated, the main side effects being grade 1–2 diarrhea and skin rash. Only 1–2% of patients develop the potentially life-threatening adverse event of interstitial pneumonia (5,6).

1. Shepherd FA, Rodrigues Pereira J, Ciuleanu T et al.; National Cancer Institute of Canada Clinical Trials Group. Erlotinib in previously treated non-small-cell lung cancer. N. Engl. J. Med. 353(2), 123–132(2005).

2. Fukuoka M, Yano S, Giaccone G et al. Multi-institutional randomized Phase II trial of gefitinib for previously treated patients with advanced non-small-cell lung cancer (the IDEAL 1 trial) [corrected]. J. Clin. Oncol. 21(12), 2237–2246(2003).

3. Kris MG, Natale RB, Herbst RS et al. Efficacy of gefitinib, an inhibitor of the epidermal growth factor receptor tyrosine kinase, in symptomatic patients with non-small cell lung cancer: a randomized trial. JAMA 290(16), 2149–2158(2003).

4. Mok TS, Wu YL, Thongprasert S et al. Gefitinib or carboplatin–paclitaxel in pulmonary adenocarcinoma. N. Engl. J. Med. 361(10), 947–957(2009).

5. Ando M, Okamoto I, Yamamoto N et al. Predictive factors for interstitial lung disease, antitumor response, and survival in non-small-cell lung cancer patients treated with gefitinib. J. Clin. Oncol. 24(16), 2549–2556(2006).

6. Takano T, Ohe Y, Kusumoto M et al. Risk factors for interstitial lung disease and predictive factors for tumor response in patients with advanced non-small cell lung cancer treated with gefitinib. Lung Cancer 45(1), 93–104(2004).
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Old 02-02-2013, 06:00 PM
gdpawel gdpawel is offline
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Default Genotype-directed Afatinib Ups Overall Survival in Some Lung Cancers?

First-line afatinib is associated with prolonged survival in treatment-naďve patients with advanced non-small cell lung cancers (NSCLC) that harbor Del19-mutant epidermal growth factor receptor (EGFR), confirms a pooled analysis of data from two large phase 3 trials. The analysis was presented at the 2014 ASCO trade show.

Afatinib “significantly improved OS [overall survival] in patients with advanced NSCLC harboring EGFR Del19 compared with chemotherapy, in two randomized trials,” concluded James Chih-Hsin Yang, MD, PhD, of the National Taiwan University Hospital in Taipei, Taiwan. “First-line afatinib should be the standard of care for EGFR Del19 patients.”

The pooled analysis is the first report that genotype-directed therapy for patients with an EGFR-mutation can improve survival, Dr. Yang said.

“There was no significant difference in OS of patients with L858R mutations,” however, cautioned Dr. Yang. “Del19 and L858R patients are two distinct populations and should be studied separately in the future.”

Nevertheless, he said that afatinib “remains a treatment option” for EGFR L858R patients.

Afatinib is approved by the U.S. Food and Drug Administration as an oral, irreversible ErbB family blocker of EGFR, HER2, ErbB3 and ErbB4.

The coauthors pooled data for 631 patients with stage IIIb/IV NSCLC who participated in the open-label phase 3 LUX-Lung 3 and LUX-Lung 6 trials, which compared afatinib with gemcitabine-cisplatin chemotherapy. The pooled analysis included data for 419 patients who received afatinib and 212 patients who received chemotherapy.

RELATED: Lung Cancer Resource Center

For patients with Del19, median OS was significantly higher among those administered afatinib (n=236; median OS, 31.7 months) than those receiving chemotherapy (n=119; median OS, 20.7 months; hazard ratio, 0.59; 95% CI: 0.45-0.77; P = 0.0001).

Reference:

Yang JCH, Sequist LV, Schuler MH et al. Abstract 8004. Presented at: 2014 American Society of Clinical Oncology (ASCO) Annual Meeting; May 30-June 3, 2014; Chicago, IL.

Citation: Genotype-directed Afatinib Ups Overall Survival in Some Lung Cancers. Chemotherapy Advisor. June 3, 2014.
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Last edited by gdpawel : 06-18-2014 at 11:03 PM. Reason: Updated information
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Old 07-12-2013, 12:01 PM
gdpawel gdpawel is offline
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Default FDA approves afatinib for a type of late-stage lung cancer

The U.S. Food and Drug Administration approved Gilotrif (afatinib) for patients with late stage (metastatic) non-small cell lung cancer (NSCLC) whose tumors express specific types of epidermal growth factor receptor (EGFR) gene mutations, as detected by an FDA-approved test.

About 85 percent of lung cancers are NSCLC, making it the most common type of lung cancer. EGFR gene mutations are present in about 10 percent of NSCLC, with the majority of these gene mutations expressing EGFR exon 19 deletions or exon 21 L858R substitution.

Gilotrif is a tyrosine kinase inhibitor that blocks proteins that promote the development of cancerous cells. It is intended for patients whose tumors express the EGFR exon 19 deletions or exon 21 L858R substitution gene mutations.

Gilotrif is being approved concurrently with the therascreen EGFR RGQ PCR Kit, a companion diagnostic that helps determine if a patient’s lung cancer cells express the EGFR mutations.

Gilotrif is the second drug approved this year for patients with untreated metastatic NSCLC whose tumors have the EGFR exon 19 deletions or exon 21 L858R substitution mutations.

In May, the FDA approved Tarceva (erlotinib) for first-line treatment of patients with NSCLC. Tarceva’s new indication was approved concurrently with the cobas EGFR Mutation Test, a companion diagnostic to identify patients with tumors having the EGFR gene mutations.

“The approval of companion diagnostic tests and drugs are important developments in oncology, as they help us bring safe and effective treatments to patients who need them,” said Alberto Gutierrez, Ph.D., director of the Office of In Vitro Diagnostics and Radiological Health in the FDA’s Center for Devices and Radiological Health.

The FDA’s approval of the therascreen EGFR RGQ PCR Kit is based on data from the clinical study used to support Gilotrif’s approval. Tumor samples from NSCLC participants in the clinical trial helped to validate the test’s use for detecting EGFR mutations in this patient population.

Gilotrif’s safety and effectiveness were established in a clinical study of 345 participants with metastatic NSCLC whose tumors harbored EGFR mutations. Participants were randomly assigned to receive Gilotrif or up to six cycles of the chemotherapy drugs pemetrexed and cisplatin.

Participants receiving Gilotrif had a delay in tumor growth (progression-free survival) that was 4.2 months later than those receiving chemotherapy. There was no statistically significant difference in overall survival.

Common side effects of Gilotrif include diarrhea, skin breakouts that resemble acne, dry skin, itching (pruritus), inflammation of the mouth, skin infection around the nails (paronychia), decreased appetite, decreased weight, inflammation of the bladder (cystitis), nose bleed, runny nose, fever, eye inflammation and low potassium levels in the blood (hypokalemia). Serious side effects include diarrhea that can result in kidney failure and severe dehydration, severe rash, lung inflammation and liver toxicity.

The FDA reviewed Gilotrif under its priority review program, which provides an expedited review for drugs that may provide safe and effective therapy when no satisfactory alternative therapy exists, or offer significant improvement compared to marketed products.

Gilotrif is marketed by Ridgefield, Conn.-based Boehringer Ingelheim Pharmaceuticals, Inc. The therascreen EGFR RGQ PCR Kit is manufactured by QIAGEN Manchester Ltd., based in the United Kingdom.

The cobas EGFR Mutation Test is manufactured by the Roche Molecular Systems in Pleasanton, Calif., and Tarceva is co-marketed by California-based Genentech, a member of the Roche Group, and OSI Pharmaceuticals of Farmingdale, N.Y.

Source: FDA.gov

One Target, One Drug, Companion Diagnostics

The part that scares me is the companion diagnostics and their companion therapies are what's being pushed as "personalized medicine" as they enable the identification of "likely" responders to therapies that work in patients with a specific molecular profile.

The headlong rush to develop pre-tests (companion diagnostics) to identify molecular predisposing mechanisms does not guarantee that a cancer drug will be effective for an "individual" patient. Nor can they, for any patient or even large group of patients, discriminate the potential for clinical activity among different cancer agents of the same class.

The drug discovery model over the last number of years has been limited to one gene/protein, one target, one drug. The "cell" is a system, an integrated, interacting network of genes, proteins and other cellular constituents that produce functions. You need to analyse the systems' response to drug treatments, not just one target or pathway.

Landscape trends suggest companion diagnostics tests in their current "one-test/one-drug" embodiment will not adequately cover decision support needs as physicians become inundated with more biomarker data likely to be interrelated, nuanced and at times even contradictory.

I would not want to be denied treatment with a targeted therapy because of gene testing. It is not a clear predictor of benefit or a lack of benefit. Many more patients could benefit from this TKI drug.

The Use of Companion Diagnostics?

[url]http://cancerfocus.org/forum/showthread.php?t=3038
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Last edited by gdpawel : 07-16-2013 at 11:59 AM. Reason: additional info
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Old 07-31-2013, 11:21 AM
gdpawel gdpawel is offline
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Default Now that Afatinib’s Approved, How Should We Use It? Newer Isn’t Necessarily Better

Howard (Jack) West, M.D.
Medical Director, Thoracic Oncology Program
Swedish Cancer Institute Seattle, Washington

Afatinib, newly christened Gilotrif, is the newest EGFR tyrosine kinase inhibitor (TKI) approved by the FDA, specifically for patients with an EGFR mutation as first line therapy. As an irreversible inhibitor of the family of receptors in which EGFR is a member, there’s a theoretical appeal that it may be more effective than reversible EGFR inhibitors (which attach to and then come off of the EGFR receptor) that are currently available, namely Tarceva (erlotinib) and/or Iressa (gefitinib), depending on where you are in the world. But what role does it play in the current lung cancer landscape? Sadly, I must confess that I don’t think it has demonstrated any incremental benefit over the EGFR inhibitors we’ve had available for years. The best evidence I can see is that Gilotrif is a more toxic version of these already available agents.

Afatinib was approved by the FDA based on the results of the LUX Lung-3 trial, which demonstrated that afatinib compared with cisplatin/Alimta (pemetrexed) led to a significantly superior response rate (56.1% vs. 22.6%, P<0.001), and 60.8% in patients with the more common exon 19 and 21 EGFR mutations) and progression-free survival (median 11.1 vs. 6.9 mo (and 13.6 mo in those with common EGFR mutations), HR=0.58, p=0.0004) compared with standard chemotherapy in previously untreated patients with advanced NSCLC and an EGFR mutation. While that’s great, it’s also exactly what we’ve already seen in SEVERAL trials of Iressa or Tarceva vs. platinum doublet chemotherapy in the same population. In fact, a few months ago, Tarceva was approved for the same indication.

Did we see evidence that afatinib prolong survival compared with chemo, in a way that we haven’t seen with Iressa or Tarceva? No. Any evidence of afatinib doing more than what we get with other EGFR TKIs? Umm…no. A few champions of afatinib have made the rather weak point that the 13.6 month median PFS in patients with the more common EGFR mutations on exon 19 or 21 is slightly longer than the 9-13.1 month median PFS seen with Iressa or Tarceva in several other trials, but that difference is very easily within the range of random effect or subtle differences between the populations in one trial vs. another. The clearest difference we actually see with afatinib compared with currently available EGFR TKIs is that afatinib is associated with more frequent and more severe side effects: more rash, more diarrhea, more nausea, more mouth sores.

What we’ve learned from nearly a decade of managing patients with an EGFR mutation is that these patients can have remarkably dramatic and prolonged responses to EGFR TKIs, but they are also often extremely sensitive to the side effects of these agents. Consequently, it can be a struggle to strike and maintain a reasonable balance of efficacy with a tolerable side effect profile for these agents over time. Moreover, lab-based studies indicate that cancer cells with an EGFR mutation are about 10 times as sensitive to EGFR inhibitors as non EGFR-mutated cancer cells, suggesting that patients with an EGFR mutated lung cancer may need a lower dose of EGFR TKI therapy to effectively treat the cancer. Though Iressa tends to have a relatively mild side effect profile, Tarceva at standard dose of 150 mg daily is very often very challenging if not prohibitively toxic for many EGFR mutation-positive patients to take on a prolonged basis. We routinely whittle down the daily dose to 50-100 mg, sometimes even 25 mg daily, to reach a balance of effective disease control and longitudinal tolerability.

In other words, with EGFR TKIs that provide an impressive but ultimately transient benefit, we want to deliver this benefit with the least toxicity possible. Very often, this means working down from the standard doses of even our better tolerated EGFR inhibitors like Tarceva and especially Iressa (where it is available). A trial is being conducted directly comparing afatinib to Iressa as first line therapy in patients with an EGFR mutation, and this will be important, though I’d want to see an improvement in overall survival for afatinib to counterbalance what I expect will be a significant increase in side effects with afatinib. But until we see the results of this trial, and in the absence of actual evidence that afatinib is convincingly more effective than Tarceva and Iressa, afatinib just represents a more toxic version of these other drugs for first line therapy in EGFR mutated patients with advanced NSCLC.
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