TTFields Optune Lua - Revision history

MesotheliomaSupport: Place inline refs in section 17: novocure_2026_pipeline, ttfields_lunar_pma, fda_hde_pathway_overview — clears "defined in not used in prior text" cite errors

2026-05-20T17:52:07Z

Place inline refs in section 17: novocure_2026_pipeline, ttfields_lunar_pma, fda_hde_pathway_overview — clears "defined in <references> not used in prior text" cite errors

← Older revision		Revision as of 17:52, 20 May 2026
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	=== The Humanitarian Device Exemption Pathway ===		=== The Humanitarian Device Exemption Pathway ===

	The NovoTTF-100L System received '''FDA approval on May 23, 2019''' under the '''Humanitarian Device Exemption (HDE) pathway''' (HDE number: H180002).<ref name="fda_hde" /><ref name="medtechdive" /> The HDE pathway was created to encourage development of treatments for rare diseases affecting fewer than 8,000 patients per year in the United States — mesothelioma qualifies with approximately 3,000 new cases annually.<ref name="west_cancer" />		The NovoTTF-100L System received '''FDA approval on May 23, 2019''' under the '''Humanitarian Device Exemption (HDE) pathway''' (HDE number: H180002).<ref name="fda_hde" /><ref name="medtechdive" /> The HDE pathway was created to encourage development of treatments for rare diseases affecting fewer than 8,000 patients per year in the United States<ref name="fda_hde_pathway_overview" /> — mesothelioma qualifies with approximately 3,000 new cases annually.<ref name="west_cancer" />

	The approved indication is the treatment of adult patients with unresectable, locally advanced or metastatic malignant pleural mesothelioma, to be used concurrently with pemetrexed and platinum-based chemotherapy.<ref name="fda_hde" /> Under HDE, the effectiveness threshold is lower than for Premarket Approval (PMA) — the device must show "probable benefit" rather than demonstrated effectiveness.<ref name="novocure_fda" />		The approved indication is the treatment of adult patients with unresectable, locally advanced or metastatic malignant pleural mesothelioma, to be used concurrently with pemetrexed and platinum-based chemotherapy.<ref name="fda_hde" /> Under HDE, the effectiveness threshold is lower than for Premarket Approval (PMA) — the device must show "probable benefit" rather than demonstrated effectiveness.<ref name="novocure_fda" />
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	As of early 2026, '''Optune Lua for malignant pleural mesothelioma remains approved exclusively under the Humanitarian Device Exemption pathway'''. NovoCure's 2025 Annual Report (Form 10-K, filed February 2026) explicitly confirms that the mesothelioma indication has not been moved to the higher Premarket Approval (PMA) pathway.<ref name="novocure_10k_2025" /> No PMA application for the mesothelioma indication has been submitted, and '''no phase 3 randomized controlled trial of TTFields in mesothelioma is registered on ClinicalTrials.gov''' as of March 2026.<ref name="ceresoli_review" /><ref name="ilcn_editorial" />		As of early 2026, '''Optune Lua for malignant pleural mesothelioma remains approved exclusively under the Humanitarian Device Exemption pathway'''. NovoCure's 2025 Annual Report (Form 10-K, filed February 2026) explicitly confirms that the mesothelioma indication has not been moved to the higher Premarket Approval (PMA) pathway.<ref name="novocure_10k_2025" /> No PMA application for the mesothelioma indication has been submitted, and '''no phase 3 randomized controlled trial of TTFields in mesothelioma is registered on ClinicalTrials.gov''' as of March 2026.<ref name="ceresoli_review" /><ref name="ilcn_editorial" />

	This regulatory standstill stands in sharp contrast to NovoCure's progress in other cancer indications. In '''February 2026 the FDA approved Optune Pax for locally advanced pancreatic cancer via the full PMA pathway''', supported by the phase 3 PANOVA-3 randomized controlled trial.<ref name="optune_pax_panova3" /> Combined with the 2024 PMA approval of Optune Lua in metastatic NSCLC (LUNAR trial) and the original PMA approvals in glioblastoma (EF-11, EF-14), mesothelioma is now '''the only HDE indication remaining in NovoCure's U.S. portfolio''' — a function of the absence of a randomized mesothelioma trial, not a regulatory barrier per se.		This regulatory standstill stands in sharp contrast to NovoCure's progress in other cancer indications. In '''February 2026 the FDA approved Optune Pax for locally advanced pancreatic cancer via the full PMA pathway''', supported by the phase 3 PANOVA-3 randomized controlled trial.<ref name="optune_pax_panova3" /><ref name="novocure_2026_pipeline" /> Combined with the 2024 PMA approval of Optune Lua in metastatic NSCLC (LUNAR trial)<ref name="ttfields_lunar_pma" /> and the original PMA approvals in glioblastoma (EF-11, EF-14), mesothelioma is now '''the only HDE indication remaining in NovoCure's U.S. portfolio''' — a function of the absence of a randomized mesothelioma trial, not a regulatory barrier per se.

	The regulatory implications matter for patients and payers:		The regulatory implications matter for patients and payers:

MesotheliomaSupport: Place inline refs in section 43: nct05538806_record — clears "defined in not used in prior text" cite errors

2026-05-20T17:52:06Z

Place inline refs in section 43: nct05538806_record — clears "defined in <references> not used in prior text" cite errors

← Older revision		Revision as of 17:52, 20 May 2026
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	=== TIGER Meso (NCT05538806) ===		=== TIGER Meso (NCT05538806) ===

	'''TIGER Meso is the principal ongoing TTFields study in mesothelioma as of 2026.'''<ref name="tiger_meso" /><ref name="tiger_detail" /><ref name="ceresoli_review" />		'''TIGER Meso is the principal ongoing TTFields study in mesothelioma as of 2026.'''<ref name="nct05538806_record" /><ref name="tiger_meso" /><ref name="tiger_detail" /><ref name="ceresoli_review" />

	* '''Design:''' Post-authorization, prospective, observational, real-world study — '''not an interventional trial''' and not a randomized comparison		* '''Design:''' Post-authorization, prospective, observational, real-world study — '''not an interventional trial''' and not a randomized comparison

MesotheliomaSupport: Fix 7b: demote body H1 to H2 (ALFRED audit #6922)

2026-05-14T23:07:43Z

Fix 7b: demote body H1 to H2 (ALFRED audit #6922)

← Older revision		Revision as of 23:07, 14 May 2026
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	}}		}}

	= Tumor Treating Fields (TTFields) / Optune Lua for Mesothelioma =		== Tumor Treating Fields (TTFields) / Optune Lua for Mesothelioma ==

	== Overview ==		== Overview ==

MesotheliomaSupport: May 2026 regulatory + STELLAR final + TIGER registry update; PMID corrections (CLEO #5514)

2026-05-06T18:13:29Z

May 2026 regulatory + STELLAR final + TIGER registry update; PMID corrections (CLEO #5514)

Show changes

MesotheliomaSupport: RON: Add OG/Twitter meta — type=Article, image=logo.png, twitter_card=summary_large_image

2026-04-25T14:19:07Z

RON: Add OG/Twitter meta — type=Article, image=logo.png, twitter_card=summary_large_image

← Older revision		Revision as of 14:19, 25 April 2026
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	\|author=WikiMesothelioma Medical Editorial Team		\|author=WikiMesothelioma Medical Editorial Team
	\|published_time=2026-03-03		\|published_time=2026-03-03
	}}		\|type=Article
			\|image=logo.png
			\|twitter_card=summary_large_image}}

	= Tumor Treating Fields (TTFields) / Optune Lua for Mesothelioma =		= Tumor Treating Fields (TTFields) / Optune Lua for Mesothelioma =

MesotheliomaSupport: Fix structural reference errors: remove orphaned/duplicate refs (RON-2026-04-05-003)

2026-04-06T09:57:31Z

Fix structural reference errors: remove orphaned/duplicate refs (RON-2026-04-05-003)

← Older revision		Revision as of 09:57, 6 April 2026
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	<ref name="dandell_treatment">[https://dandell.com/mesothelioma-treatment/ Mesothelioma Treatment Options], Danziger & De Llano, LLP</ref>		<ref name="dandell_treatment">[https://dandell.com/mesothelioma-treatment/ Mesothelioma Treatment Options], Danziger & De Llano, LLP</ref>
	<ref name="dandell_legal">[https://dandell.com/mesothelioma-lawsuits/ Mesothelioma Lawsuits and Legal Options], Danziger & De Llano, LLP</ref>		<ref name="dandell_legal">[https://dandell.com/mesothelioma-lawsuits/ Mesothelioma Lawsuits and Legal Options], Danziger & De Llano, LLP</ref>
	~~<ref name="dandell_diagnosis">[https://dandell.com/mesothelioma-diagnosis/ Mesothelioma Diagnosis Guide], Danziger & De Llano, LLP</ref>~~
	~~<ref name="dandell_compensation">[https://dandell.com/mesothelioma-compensation/ Mesothelioma Compensation and Settlements], Danziger & De Llano, LLP</ref>~~
	~~<ref name="dandell_trust">[https://dandell.com/asbestos-trust-funds/ Asbestos Trust Fund Claims], Danziger & De Llano, LLP</ref>~~
	~~<ref name="dandell_types">[https://dandell.com/types-of-mesothelioma/ Types of Mesothelioma], Danziger & De Llano, LLP</ref>~~
	~~<ref name="dandell_asbestos">[https://dandell.com/asbestos-exposure/ Asbestos Exposure and Health Risks], Danziger & De Llano, LLP</ref>~~
	~~<ref name="dandell_veterans">[https://dandell.com/mesothelioma-veterans/ Mesothelioma and Veterans], Danziger & De Llano, LLP</ref>~~
	<ref name="mlc_treatment">[https://mesotheliomalawyercenter.org/treatment/ Mesothelioma Treatment Overview], Mesothelioma Lawyer Center</ref>		<ref name="mlc_treatment">[https://mesotheliomalawyercenter.org/treatment/ Mesothelioma Treatment Overview], Mesothelioma Lawyer Center</ref>
	<ref name="mlc_clinical_trials">[https://mesotheliomalawyercenter.org/clinical-trials/ Mesothelioma Clinical Trials], Mesothelioma Lawyer Center</ref>		<ref name="mlc_clinical_trials">[https://mesotheliomalawyercenter.org/clinical-trials/ Mesothelioma Clinical Trials], Mesothelioma Lawyer Center</ref>
	~~<ref name="mlc_diagnosis">[https://mesotheliomalawyercenter.org/diagnosis/ Mesothelioma Diagnosis Information], Mesothelioma Lawyer Center</ref>~~
	~~<ref name="mlc_stages">[https://mesotheliomalawyercenter.org/stages/ Mesothelioma Stages and Staging], Mesothelioma Lawyer Center</ref>~~
	~~<ref name="mlc_prognosis">[https://mesotheliomalawyercenter.org/prognosis/ Mesothelioma Prognosis and Life Expectancy], Mesothelioma Lawyer Center</ref>~~
	~~<ref name="mlc_pleural">[https://mesotheliomalawyercenter.org/pleural-mesothelioma/ Pleural Mesothelioma Guide], Mesothelioma Lawyer Center</ref>~~
	<ref name="mesonet_treatment">[https://mesothelioma.net/mesothelioma-treatment/ Mesothelioma Treatment Options], Mesothelioma.net</ref>		<ref name="mesonet_treatment">[https://mesothelioma.net/mesothelioma-treatment/ Mesothelioma Treatment Options], Mesothelioma.net</ref>
	<ref name="mesonet_emerging">[https://mesothelioma.net/emerging-treatments/ Emerging Mesothelioma Treatments], Mesothelioma.net</ref>		<ref name="mesonet_emerging">[https://mesothelioma.net/emerging-treatments/ Emerging Mesothelioma Treatments], Mesothelioma.net</ref>
	<ref name="mesonet_support">[https://mesothelioma.net/mesothelioma-support/ Mesothelioma Patient Support Resources], Mesothelioma.net</ref>		<ref name="mesonet_support">[https://mesothelioma.net/mesothelioma-support/ Mesothelioma Patient Support Resources], Mesothelioma.net</ref>
	~~<ref name="mesonet_clinical">[https://mesothelioma.net/clinical-trials/ Mesothelioma Clinical Trials Information], Mesothelioma.net</ref>~~
	~~<ref name="mesonet_types">[https://mesothelioma.net/types-of-mesothelioma/ Types of Mesothelioma], Mesothelioma.net</ref>~~
	<ref name="mesoatty_treatment">[https://mesotheliomaattorney.com/mesothelioma-treatment/ Mesothelioma Treatment Advances], MesotheliomaAttorney.com</ref>		<ref name="mesoatty_treatment">[https://mesotheliomaattorney.com/mesothelioma-treatment/ Mesothelioma Treatment Advances], MesotheliomaAttorney.com</ref>
	<ref name="mesoatty_options">[https://mesotheliomaattorney.com/mesothelioma-legal-options/ Mesothelioma Legal Options], MesotheliomaAttorney.com</ref>		<ref name="mesoatty_options">[https://mesotheliomaattorney.com/mesothelioma-legal-options/ Mesothelioma Legal Options], MesotheliomaAttorney.com</ref>
	~~<ref name="mesoatty_compensation">[https://mesotheliomaattorney.com/mesothelioma-compensation/ Mesothelioma Compensation Guide], MesotheliomaAttorney.com</ref>~~
	<ref name="novocure_patient">[https://www.novocure.com/patient-support/ NovoCure Patient Support and Financial Assistance], NovoCure</ref>		<ref name="novocure_patient">[https://www.novocure.com/patient-support/ NovoCure Patient Support and Financial Assistance], NovoCure</ref>
	</references>		</references>

MesotheliomaSupport: Add differentiated triple GEO format

2026-03-08T22:11:28Z

Add differentiated triple GEO format

@@ Line 57: / Line 57: @@
 | style="padding:10px;" | MPM, GBM (new & recurrent), NSCLC
 |}
 == Key Facts ==
@@ Line 62: / Line 75: @@
 {| class="wikitable" style="width:100%; border-collapse:collapse; margin:1em 0;"
 |-
-! style="background:#1a5276; color:white; padding:12px; text-align:left;" | Key Facts: TTFields / Optune Lua for Mesothelioma
+! style="background:#1a5276; color:white; padding:10px;" | Metric
 |-
-| style="padding:15px;" |
+| style="padding:10px; font-weight:bold; border-bottom:1px solid #dee2e6;" | Dermatologic Adverse Events
-* TTFields are low-intensity alternating electric fields (150 kHz for mesothelioma) that disrupt cancer cell division while sparing normal cells<ref name="mechanisms_nature" />
+| style="padding:10px; border-bottom:1px solid #dee2e6;" | 58% any grade; 53% grade 1-2 dermatitis; 6% grade 3-4 (meta-analysis, N=192)<ref name="skin_guidance" /><ref name="ceresoli_review" />
-* The STELLAR trial demonstrated '''18.2-month median overall survival''' in 80 patients with unresectable MPM — a 50% improvement over the 12.1-month historical control with chemotherapy alone<ref name="ceresoli_review" />
+|-
-* FDA granted Humanitarian Device Exemption approval on '''May 23, 2019''' — the first new mesothelioma treatment approved since pemetrexed in 2004<ref name="fda_hde" /><ref name="medtechdive" />
+| style="padding:10px; font-weight:bold; border-bottom:1px solid #dee2e6;" | FDA Approval
-* Patients with '''epithelioid histology''' achieved median OS of '''21.2 months''' versus 12.1 months for non-epithelioid subtypes<ref name="ceresoli_review" />
+| style="padding:10px; border-bottom:1px solid #dee2e6;" | May 23, 2019 — Humanitarian Device Exemption (H180002) for unresectable MPM<ref name="fda_hde" />
-* The only device-related adverse event is localized skin irritation — '''66% grade 1-2''' and '''5% grade 3''' — with no systemic toxicity<ref name="ceresoli_review" />
+|-
-* The second-generation Optune Lua weighs '''1.2 kg''' (down from 2.7 kg) and is worn continuously for at least '''18 hours per day'''<ref name="ceresoli_review" />
+| style="padding:10px; font-weight:bold;" | Device Compliance (STELLAR)
-* More than '''110 U.S. hospitals''' are certified to provide TTFields therapy for mesothelioma<ref name="novocure_history" />
+| style="padding:10px;" | Median 16.3 hours/day during first 3 months; recommended minimum 18 hours/day (75%)<ref name="ceresoli_review" /><ref name="ilcn_practice" />
 |}
@@ Line 579: / Line 613: @@
 TTFields therapy is approved for adults with unresectable, locally advanced or metastatic malignant pleural mesothelioma. Patients must not have implanted electronic medical devices (pacemakers, defibrillators), known sensitivity to conductive gels, or require supplemental oxygen. Treatment is initiated at certified centers where NovoCure support specialists provide training for patients and caregivers.<ref name="fda_hde" /><ref name="fda_ssed" />
 == Related Pages ==

MesotheliomaSupport: Create comprehensive TTFields/Optune Lua medical wiki page — STELLAR trial, FDA HDE approval, mechanism, treatment protocol, side effects, cost, guidelines

2026-03-04T02:37:47Z

Create comprehensive TTFields/Optune Lua medical wiki page — STELLAR trial, FDA HDE approval, mechanism, treatment protocol, side effects, cost, guidelines

Show changes