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Mobocertinib

Mobocertinib, marketed under the brand name Exkivity, was an oral irreversible tyrosine kinase inhibitor specifically designed to target epidermal growth factor receptor (EGFR) exon 20 insertion mutations in non-small cell lung cancer (NSCLC). Developed by Takeda Pharmaceuticals, it received accelerated approval from the U.S. Food and Drug Administration (FDA) on September 15, 2021, for the treatment of adult patients with locally advanced or metastatic NSCLC harboring EGFR exon 20 insertion mutations, as detected by an FDA-approved test, whose disease had progressed on or after platinum-based chemotherapy.^[1]^[2] The drug's mechanism of action involves covalent binding to cysteine 797 in the EGFR kinase domain, selectively inhibiting mutant EGFR forms at concentrations 1.5- to 10-fold lower than those required for wild-type EGFR, thereby blocking downstream signaling pathways that promote tumor cell proliferation.^[3]^[2] In the pivotal phase 1/2 clinical trial (EXCLAIM-1, NCT02716116), mobocertinib demonstrated an objective response rate of 28% (95% CI: 20%-37%) and a median duration of response of 17.5 months among 114 efficacy-evaluable patients, supporting its accelerated approval under the FDA's oncology expedited programs, including priority review, breakthrough therapy, and orphan drug designations.^[1]^[3] Common adverse reactions included diarrhea (92% incidence), rash (78%), and nausea (37%), with serious risks such as QT interval prolongation leading to a boxed warning; the drug's half-life was approximately 18 hours, with primary metabolism via CYP3A enzymes.^[1]^[2]^[3] However, the confirmatory phase 3 EXCLAIM-2 trial (NCT04129502) failed to meet its primary endpoint of progression-free survival compared to platinum-based chemotherapy in the first-line setting, prompting Takeda to announce a voluntary global withdrawal in October 2023.^[3] The FDA officially withdrew approval of the new drug application on July 15, 2024, rendering mobocertinib no longer available for clinical use as of November 2025.^[4]^[5]

Medical uses

Indications

Mobocertinib was indicated for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring epidermal growth factor receptor (EGFR) exon 20 insertion mutations, as detected by an FDA-approved test, whose disease had progressed on or after prior platinum-based chemotherapy.^[6] EGFR exon 20 insertion mutations constitute a specific genetic subtype, occurring in approximately 4–10% of EGFR-mutated NSCLC cases.^[7] The U.S. Food and Drug Administration (FDA) granted accelerated approval for this indication on September 15, 2021, based on overall response rate and duration of response from single-arm trials.^[1] Continued approval was contingent on verification and description of clinical benefit in confirmatory trials.^[6] Mobocertinib was not approved for first-line therapy or for any other cancer types.^[6] In October 2023, following results from a phase 3 confirmatory trial that failed to demonstrate clinical benefit, Takeda initiated a voluntary withdrawal of mobocertinib from the U.S. and global markets.^[8] The FDA approved the withdrawal on July 15, 2024, rendering the drug unavailable as of that date.^[4]

Dosage and administration

Mobocertinib was administered orally at a recommended dose of 160 mg once daily until disease progression or unacceptable toxicity.^[6] The capsules could be taken with or without food and should have been swallowed whole without opening, crushing, or chewing; if a dose was missed by more than 6 hours or vomiting occurred after administration, the dose should have been skipped and the next dose taken as scheduled.^[6] Concomitant use of grapefruit or grapefruit juice should have been avoided, as should strong or moderate CYP3A inhibitors and inducers, which could alter mobocertinib exposure and affect efficacy or increase toxicity risk.^[6] Dose modifications were essential to manage adverse reactions, with the first dose reduction to 120 mg once daily and the second to 80 mg once daily; further reductions below 80 mg were not recommended.^[6] Therapy should have been interrupted for intolerable or recurrent Grade 2 or any Grade 3 adverse reactions (such as diarrhea), Grade 3 QTc prolongation (greater than 500 ms), or suspected interstitial lung disease (ILD), and resumed at the same or reduced dose upon recovery to baseline or Grade 1.^[6] For Grade 4 reactions, including severe diarrhea or QTc prolongation, treatment should have been withheld and resumed at a reduced dose if recovery occurred within 2 weeks, with permanent discontinuation required for recurrence or if recovery took longer; permanent discontinuation was also mandated for confirmed ILD, recurrent Grade 4 events, or significant cardiac toxicities like Grade 3 or 4 left ventricular dysfunction.^[6] Common adverse effects like diarrhea often necessitated these adjustments.^[6] During mobocertinib therapy, patients required regular monitoring, including electrocardiograms (ECGs) to assess the QTc interval at baseline and periodically thereafter, with increased frequency for those at risk of prolongation.^[6] Electrolyte levels, particularly potassium, calcium, magnesium, and phosphorus, should have been monitored prior to initiation and as clinically indicated, especially in cases of diarrhea; renal function and cardiac ejection fraction assessments were also recommended at baseline and during treatment to detect potential complications early.^[6]

Pharmacology

Mechanism of action

Mobocertinib is an irreversible, small-molecule tyrosine kinase inhibitor (TKI) that covalently binds to the cysteine residue at position 797 (Cys797) in the kinase domain of epidermal growth factor receptor (EGFR).^[9] This covalent binding mechanism allows for prolonged inhibition of EGFR signaling, distinguishing it from reversible TKIs.^[10] The drug selectively targets EGFR exon 20 insertion (ex20ins) mutations, which lead to constitutive activation of the receptor and confer resistance to first- and third-generation TKIs such as osimertinib.^[11] These mutations alter the EGFR kinase domain, reducing the efficacy of non-covalent inhibitors, but mobocertinib's irreversible binding overcomes this by directly engaging the conserved cysteine.^[9] In non-small cell lung cancer (NSCLC) harboring EGFR ex20ins mutations, mobocertinib inhibits EGFR phosphorylation, thereby suppressing downstream signaling pathways including RAS/MAPK, PI3K/AKT, and STAT, which ultimately decreases cancer cell proliferation and survival.^[10] Structurally, mobocertinib features a pyrimidine-based core appended with an acrylamide warhead that facilitates the covalent reaction with Cys797.^[11] Its potency against ex20ins variants, such as A767_V769dupASV, shows IC50 values ranging from 4.3 to 22.5 nM, compared to 34.5 nM for wild-type EGFR, demonstrating approximately 8-fold selectivity.^[11] At therapeutic concentrations, mobocertinib exhibits no significant inhibition of other kinases beyond the EGFR family.^[9]

Pharmacokinetics

Mobocertinib is rapidly absorbed after oral administration, achieving a median time to maximum plasma concentration (Tmax) of 4 hours (range: 1–8 hours).^[6] The absolute oral bioavailability is approximately 37% (mean, coefficient of variation [CV] 50%).^[6] Administration with a high-fat or low-fat meal results in no clinically meaningful changes in area under the curve (AUC) or maximum concentration (Cmax).^[6] The apparent steady-state volume of distribution (Vss/F) for mobocertinib is 3,509 L (mean, CV 38%), suggesting extensive tissue distribution.^[6] Mobocertinib is highly bound to plasma proteins (99.3%), primarily to serum albumin and alpha-1-acid glycoprotein.^[6] Upon repeated daily dosing at 160 mg, no clinically meaningful accumulation occurs, with a geometric mean accumulation ratio of approximately 1.03 for AUC.^[6]^[12] Mobocertinib is extensively metabolized in the liver, predominantly by cytochrome P450 3A (CYP3A) enzymes, with minor contributions from CYP2D6.^[6] The primary circulating metabolites are the active compounds AP32960 (36% of total AUC, equipotent to parent drug) and AP32914 (4% of total AUC, equipotent to parent drug).^[6] AP32960 exhibits a longer elimination half-life of 24 hours compared to 18 hours for mobocertinib and AP32914.^[13] The terminal elimination half-life of mobocertinib is 18 hours (geometric mean, CV 21%).^[6] The apparent oral clearance (CL/F) is 138 L/h (mean, CV 43%) following a single 160 mg dose.^[6] After oral administration of radiolabeled mobocertinib, approximately 76% of the dose is excreted in feces (6% as unchanged drug) and 4% in urine (<1% as unchanged drug), with the remainder as metabolites.^[6] Pharmacokinetics of mobocertinib show no clinically meaningful differences based on age (28–82 years), sex, race/ethnicity, or body weight (39–133 kg).^[6] Similarly, mild to moderate renal impairment (estimated glomerular filtration rate 30–89 mL/min) or mild hepatic impairment (Child-Pugh class A) does not require dose adjustments.^[6] However, strong CYP3A inhibitors increase combined AUC of mobocertinib plus active metabolites by 374–419%, while strong inducers decrease it by 92%; dose modifications are recommended with moderate CYP3A modulators.^[6]

Safety profile

Adverse effects

The most common adverse reactions associated with mobocertinib, occurring in ≥20% of patients in the pivotal EXCLAIM study (N=114), were predominantly gastrointestinal and dermatological in nature. Diarrhea affected 92% of patients, with most cases being grade 1 or 2 and only 22% reaching grade 3 or higher; rash occurred in 78% (1.8% grade ≥3); nausea in 37% (4% grade ≥3); vomiting in 40% (3% grade ≥3); stomatitis in 46% (4% grade ≥3); decreased appetite in 39%; paronychia in 39%; fatigue in 29% (4% grade ≥3); and dry skin in 32%.^[6] Laboratory abnormalities were also frequent, with decreased hemoglobin levels observed in approximately 60% of patients (4% grade ≥3, reflecting anemia); increased alanine aminotransferase (ALT) in 22% (3% grade ≥3) and aspartate aminotransferase (AST) in 21% (1.8% grade ≥3); hypokalemia (decreased potassium) in 29% (5% grade ≥3). Stomatitis-related events contributed to oral toxicities, often overlapping with mucositis reports.^[6]^[14] Adverse reactions led to permanent discontinuation in 17% to 19% of patients, most commonly due to diarrhea (approximately 4%), nausea (2%), and rash (2%). Dose interruptions occurred in 51% of patients, primarily for gastrointestinal effects like diarrhea, nausea, and vomiting, while dose reductions affected 25%, mainly for diarrhea. Skin toxicities, such as rash, paronychia, and dry skin, were typically managed with topical agents, and gastrointestinal effects like diarrhea and nausea were addressed using antidiarrheals and supportive care. QT prolongation was reported in 10% of patients (3.5% grade ≥3), warranting monitoring.^[6]^[14]

Warnings and precautions

Mobocertinib is associated with a risk of QT interval prolongation, which can lead to torsades de pointes, a potentially life-threatening arrhythmia.^[6] This risk is heightened when used concomitantly with strong CYP3A inhibitors or moderate CYP3A inducers, and such combinations are contraindicated.^[6] Patients with congenital long QT syndrome should avoid mobocertinib due to increased susceptibility.^[6] Baseline electrocardiograms (ECGs) and electrolyte levels should be assessed prior to initiation, with periodic monitoring recommended during treatment, particularly in patients with risk factors such as hypokalemia or concurrent use of QT-prolonging medications.^[6] Dose interruption or reduction is advised for QTc prolongation greater than 500 msec or an increase exceeding 60 msec from baseline, and permanent discontinuation is required for recurrent severe events or torsades de pointes.^[6] Severe diarrhea is a common and potentially serious adverse effect of mobocertinib that can result in dehydration, electrolyte imbalances, acute kidney injury, or renal failure if not managed promptly.^[6] Patients should initiate loperamide at the first sign of loose stools, escalating to additional antidiarrheal therapies such as octreotide if symptoms persist beyond 24 hours or worsen.^[6] The drug should be withheld for grade 3 or 4 diarrhea and resumed at a reduced dose upon resolution to grade 1 or less, with permanent discontinuation considered for recurrent severe episodes.^[6] Adequate hydration and electrolyte replacement are essential during episodes of diarrhea.^[6] Interstitial lung disease (ILD) or pneumonitis can occur with mobocertinib, with an incidence of 4.3% (including 0.8% Grade 3 and 1.2% fatal cases) in the clinical safety population, and cases may be severe or fatal.^[6] Patients should be monitored for new or worsening respiratory symptoms such as dyspnea, cough, or fever, and mobocertinib should be withheld if ILD or pneumonitis is suspected.^[6] Upon confirmation via imaging or clinical evaluation, permanent discontinuation is recommended, and corticosteroid therapy may be initiated for treatment.^[6] Mobocertinib poses a risk of embryo-fetal toxicity. Based on findings from animal studies, mobocertinib can cause fetal harm when administered to pregnant women. In animal reproduction studies, oral administration of mobocertinib to pregnant rats during the period of organogenesis resulted in embryolethality and maternal toxicity at plasma exposures approximately 1.7 times the human exposure based on AUC at the 160 mg once daily clinical dose.^[6] Females of reproductive potential and males with female partners of reproductive potential should use effective non-hormonal contraception during treatment and for one month (females) or one week (males) after the last dose.^[6] Pregnancy testing is advised prior to initiation in females of reproductive potential.^[6] Drug interactions with mobocertinib require careful management to mitigate risks of QT prolongation and altered pharmacokinetics.^[6] Concurrent use with QT interval-prolonging drugs, such as certain antiarrhythmics (e.g., amiodarone), should be avoided.^[6] Strong CYP3A inhibitors like ketoconazole are contraindicated, while moderate CYP3A inhibitors necessitate a dose reduction of mobocertinib to 160 mg daily with close QTc monitoring.^[6] For moderate CYP3A inducers like rifampin, alternative therapies without inducing effects are preferred, or dose adjustments may be required if coadministration is unavoidable.^[6] Additional precautions include monitoring for hepatotoxicity, as elevations in transaminases may occur; liver function tests should be performed periodically.^[6] Mobocertinib has not been studied in patients with severe renal or hepatic impairment, and its use is not routinely recommended in these populations without careful consideration of risks and benefits.^[6]

Development and regulatory history

Discovery and preclinical development

Mobocertinib (TAK-788) was developed by ARIAD Pharmaceuticals, Inc., with initial research beginning around 2014 to address the unmet medical need in non-small cell lung cancer (NSCLC) harboring epidermal growth factor receptor (EGFR) exon 20 insertion (ex20ins) mutations, which confer resistance to approved tyrosine kinase inhibitors (TKIs) targeting common EGFR alterations. The compound's structure was first disclosed in a 2015 patent application by ARIAD, highlighting its potential as a targeted therapy for this underserved patient population.^[15] ARIAD was acquired by Takeda Pharmaceutical Company Limited in 2017, after which development continued under Takeda's oncology division, Millennium Pharmaceuticals, Inc.^[16] The discovery of mobocertinib involved structure-guided medicinal chemistry optimization, starting from reversible EGFR inhibitors and evolving toward irreversible covalent binders to enhance potency and selectivity against ex20ins mutants. The final molecule features a pyrimidine core appended with a Michael acceptor warhead that forms a covalent bond with Cys797 in the EGFR kinase domain, enabling prolonged target engagement. Iterative modifications improved selectivity, achieving greater than 100-fold preference for ex20ins variants over wild-type EGFR (e.g., IC50 of 34.5 nM for wild-type vs. <10 nM for ex20ins). The compound also showed potent activity against other EGFR mutants, including del19/T790M (IC50 of 6.3 nM).^[15] In preclinical efficacy studies, mobocertinib demonstrated potent inhibition of EGFR ex20ins-driven proliferation in engineered Ba/F3 cell lines, with IC50 values below 10 nM for representative insertions like V769_D770insASV (11 nM). Oral dosing in Ba/F3 ASV xenograft mouse models led to significant tumor regression at 100 mg/kg, supporting its advancement as an oral candidate. Safety profiling revealed a favorable therapeutic index, with cytotoxicity in non-transfected Ba/F3 cells occurring only at much higher concentrations (IC50 of 3946 nM), and minimal off-target effects, inhibiting just 6% of a panel of 490 kinases at 1 μM. These findings, detailed in a seminal 2022 publication, underscored mobocertinib's promise for selective targeting of EGFR ex20ins NSCLC.^[15]

Clinical trials

The pivotal clinical evaluation of mobocertinib occurred in the phase 1/2 EXCLAIM trial (NCT02716116), an open-label, multicenter, nonrandomized study conducted across 39 sites in Asia, Europe, and North America.^[14] This three-part trial included dose-escalation, expansion, and extension (EXCLAIM) cohorts, enrolling 114 platinum-pretreated patients with EGFR exon 20 insertion (ex20ins)-positive metastatic non-small cell lung cancer (NSCLC), all of whom had received prior platinum-based chemotherapy.^[14] The recommended phase 2 dose was established as 160 mg orally once daily, demonstrating antitumor activity with a blinded independent review committee (BIRC)-confirmed objective response rate (ORR) of 28% (95% CI, 20%-37%) in the platinum-pretreated cohort.^[14] Median duration of response (DOR) was 17.5 months (95% CI, 7.4-20.3 months), and median progression-free survival (PFS) was 7.3 months (95% CI, 5.5-9.2 months).^[14] These results from the EXCLAIM cohort supported the accelerated regulatory approval of mobocertinib for this indication.^[14] The phase 3 EXCLAIM-2 trial (NCT04129502) was a randomized, open-label, multicenter study comparing mobocertinib (160 mg daily) against platinum-based chemotherapy (pemetrexed plus carboplatin or cisplatin) as first-line therapy in 354 patients with untreated EGFR ex20ins-positive locally advanced or metastatic NSCLC.^[17] The trial did not meet its primary endpoint of PFS superiority, with a median PFS of 9.6 months in both arms (hazard ratio [HR] 1.04, 95% CI 0.77-1.39; p=0.803) as assessed by BIRC.^[17] BIRC-confirmed ORR was 32% (95% CI, 26%-40%) with mobocertinib versus 30% (95% CI, 24%-38%) with chemotherapy. This failure to demonstrate benefit over standard chemotherapy contributed to the decision to discontinue development and withdraw marketing authorization for mobocertinib.^[17] Earlier phase 1b expansion cohorts within the EXCLAIM trial confirmed mobocertinib's activity in EGFR ex20ins NSCLC, building on dose-escalation findings to support further evaluation.^[14] No head-to-head clinical trials have compared mobocertinib directly with other targeted therapies for EGFR ex20ins NSCLC, such as amivantamab.^[17] Subgroup analyses from the phase 1/2 EXCLAIM trial showed consistent efficacy across common EGFR ex20ins variants (e.g., A763_Y764insAQEA, V769_D770insASV, and others), with ORR ranging from 25% to 32% and median PFS around 7.3-7.4 months, without clear genotype-specific differences.^[14] Approximately 71% of patients were never-smokers, a demographic in which EGFR ex20ins mutations are more prevalent, though specific response rates by smoking status were not stratified to show differential efficacy.^[14] Safety data from these trials aligned with post-approval observations, including a high incidence of any-grade diarrhea (91% in the platinum-pretreated cohort of EXCLAIM), which was mostly manageable with supportive care.^[14]

Approval and discontinuation

Takeda Pharmaceuticals submitted a New Drug Application (NDA) for mobocertinib to the U.S. Food and Drug Administration (FDA) on December 23, 2020, requesting accelerated approval under priority review for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring epidermal growth factor receptor (EGFR) exon 20 insertion mutations who had received prior platinum-based chemotherapy.^[18] The FDA granted priority review in April 2021, along with prior breakthrough therapy designation in April 2020 and orphan drug designation in 2019.^[19]^[20] On September 15, 2021, the FDA granted accelerated approval to mobocertinib (branded as Exkivity) based on objective response rate (ORR) and duration of response (DOR) data from the phase 1/2 EXCLAIM trial.^[1] As part of the accelerated approval, Takeda was required to conduct a confirmatory phase 3 trial, EXCLAIM-2 (NCT04129502), which enrolled 354 patients starting in late 2019 to verify clinical benefit by comparing mobocertinib to platinum-based chemotherapy in the first-line setting for EGFR exon 20 insertion-positive advanced NSCLC.^[21] In October 2023, following an interim analysis of EXCLAIM-2 that showed failure to meet the primary endpoint of progression-free survival with no new safety signals but lack of benefit over chemotherapy, Takeda announced plans for voluntary withdrawal of mobocertinib's approval in the United States and globally where authorized.^[8] The company requested withdrawal of the NDA on March 15, 2024, which the FDA approved on July 15, 2024, rendering the drug no longer commercially available in the U.S. as of April 2024 and continuing through 2025.^[4] Internationally, the European Medicines Agency (EMA) marketing authorization application for mobocertinib was withdrawn by Takeda on July 20, 2022 prior to any approval decision.^[12] The drug received approval from China's National Medical Products Administration (NMPA) in January 2023 as the first therapy for EGFR exon 20 insertion-positive NSCLC, but development was subsequently halted worldwide following the EXCLAIM-2 results.^[22] No approval was granted in Japan by the Pharmaceuticals and Medical Devices Agency (PMDA). The withdrawal has prompted patients previously on mobocertinib to transition to alternative therapies, such as sunvozertinib, which received FDA accelerated approval on July 2, 2025 for similar EGFR exon 20 insertion-positive NSCLC indications after platinum-based chemotherapy.

References

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