FUTIBATINIB - Generic Drug Details

What are the generic sources for futibatinib and what is the scope of freedom to operate?

Futibatinib is the generic ingredient in one branded drug marketed by Taiho Oncology and is included in one NDA. There are three patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Futibatinib has sixty-nine patent family members in twenty-five countries.

One supplier is listed for this compound.

Summary for FUTIBATINIB

International Patents:	69
US Patents:	3
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	32
Clinical Trials:	10
Patent Applications:	78
What excipients (inactive ingredients) are in FUTIBATINIB?	FUTIBATINIB excipients list
DailyMed Link:	FUTIBATINIB at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for FUTIBATINIB

Constraining patent/regulatory exclusivity:

TREATMENT OF ADULT PATIENTS WITH PREVIOUSLY TREATED, UNRESECTABLE, LOCALLY ADVANCED OR METASTATIC INTRAHEPATIC CHOLANGIOCARCINOMA HARBORING FIBROBLAST GROWTH FACTOR RECEPTOR 2 (FGFR2) GENE FUSIONS OR OTHER REARRANGEMENTS

Dosage:

TABLET;ORAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for FUTIBATINIB

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Accord Healthcare, Inc.	Phase 3
Zymeworks Inc.	Phase 3
National Cancer Institute, France	Phase 3

See all FUTIBATINIB clinical trials

Pharmacology for FUTIBATINIB

Drug Class	Kinase Inhibitor
Mechanism of Action	Breast Cancer Resistance Protein Inhibitors Fibroblast Growth Factor Receptor Inhibitors P-Glycoprotein Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for FUTIBATINIB

L01EN	Fibroblast growth factor receptor (FGFR) tyrosine kinase inhibitors
L01E	PROTEIN KINASE INHIBITORS
L01	ANTINEOPLASTIC AGENTS
L	Antineoplastic and immunomodulating agents

US Patents and Regulatory Information for FUTIBATINIB

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Taiho Oncology	LYTGOBI	futibatinib	TABLET;ORAL	214801-001	Sep 30, 2022		RX	Yes	Yes	11,833,151		Y
Taiho Oncology	LYTGOBI	futibatinib	TABLET;ORAL	214801-001	Sep 30, 2022		RX	Yes	Yes	10,434,103		Y	Y
Taiho Oncology	LYTGOBI	futibatinib	TABLET;ORAL	214801-001	Sep 30, 2022		RX	Yes	Yes	9,108,973		Y	Y
Taiho Oncology	LYTGOBI	futibatinib	TABLET;ORAL	214801-001	Sep 30, 2022		RX	Yes	Yes

EU/EMA Drug Approvals for FUTIBATINIB

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Taiho Pharma Netherlands B.V.	Lytgobi	futibatinib	EMEA/H/C/005627 Lytgobi monotherapy is indicated for the treatment of adult patients with locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or rearrangement that have progressed after at least one prior line of systemic therapy.	Authorised	no	no	no	2023-07-04

International Patents for FUTIBATINIB

Country	Patent Number	Title	Estimated Expiration
Taiwan	I508964
Japan	6190079
Brazil	112020018697	composição farmacêutica incluindo alquilsulfato de sódio
Poland	2657233

Supplementary Protection Certificates for FUTIBATINIB

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2657233	CA 2023 00036	Denmark		PRODUCT NAME: FUTIBATINIB ELLER ET SALT DERAF; REG. NO/DATE: EU/1/23/1741 20230706
2657233	CR 2023 00036	Denmark		PRODUCT NAME: FUTIBATINIB ELLER ET SALT DERAF; REG. NO/DATE: EU/1/23/1741 20230706
2657233	301254	Netherlands		PRODUCT NAME: FUTIBATINIB OF EEN ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/23/1741 20230706
2657233	122023000066	Germany		PRODUCT NAME: FUTIBATINIB ODER EIN SALZ DAVON; REGISTRATION NO/DATE: EU/1/23/1741 20230704

FUTIBATINIB Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Futibatinib

Introduction to Futibatinib

Futibatinib, marketed as Lytgobi by Taiho Oncology, Inc., is a next-generation, covalently binding FGFR1-4 inhibitor that has garnered significant attention for its efficacy in treating intrahepatic cholangiocarcinoma (iCCA) with FGFR2 gene fusions or other rearrangements. Here, we delve into the market dynamics and financial trajectory of this promising drug.

Regulatory Approvals and Designations

Futibatinib received accelerated approval from the U.S. Food and Drug Administration (FDA) on September 30, 2022, for adult patients with previously treated, unresectable, locally advanced or metastatic iCCA harboring FGFR2 gene fusions or other rearrangements[1][3][4].

This approval was facilitated by the FDA's Real-Time Oncology Review (RTOR) pilot program and the Assessment Aid, which streamlined the data submission process. Additionally, futibatinib was granted priority review, breakthrough designation, and orphan drug designation, highlighting its potential as a critical treatment for a rare and serious condition[1].

Clinical Trial Outcomes and Efficacy

The pivotal Phase 2 FOENIX-CCA2 clinical trial demonstrated that futibatinib is an effective treatment for FGFR2 fusion/rearrangement-positive iCCA. The trial showed an objective response rate (ORR) of 42% and a median duration of response of 9.7 months. These outcomes were consistent across various patient subgroups, including those with heavily pretreated disease and older adults[2][3][5].

The trial also indicated that futibatinib resulted in durable responses and survival that surpassed historical data with chemotherapy in patients with previously treated iCCA. The median progression-free survival was 9.0 months, and the overall survival was 21.7 months[2][3].

Market Impact and Competitive Landscape

Futibatinib's approval marks a significant advancement in the treatment of iCCA, a cancer type with a poor prognosis and limited therapeutic options. The drug's covalent binding mechanism and low susceptibility to acquired resistance differentiate it from other FGFR inhibitors, which often face challenges with drug resistance[5].

In the competitive landscape, futibatinib stands out due to its robust preclinical and clinical data, particularly its ability to maintain patient quality of life and its manageable safety profile. This positions futibatinib as a preferred option for patients with FGFR2-altered tumors, potentially capturing a substantial market share in the targeted therapy segment for iCCA[2][5].

Financial Projections and Revenue Potential

Given its accelerated approval and the unmet medical need in the iCCA market, futibatinib is expected to generate significant revenue. The drug's efficacy and safety profile, combined with its orphan drug designation, suggest a high potential for market penetration.

The financial trajectory of futibatinib is likely to be influenced by several factors, including the size of the patient population with FGFR2 alterations, the drug's pricing strategy, and the outcomes of ongoing and future clinical trials. As the drug continues to demonstrate durable responses and improved survival rates, it is anticipated to become a key player in the oncology market, particularly in the niche segment of FGFR-altered cancers[3][5].

Global Market Expansion

In addition to its approval in the U.S., futibatinib has received conditional marketing authorization from the European Medicines Agency (EMA) for the second-line treatment of locally advanced or metastatic cholangiocarcinoma characterized by FGFR2 fusions or rearrangements. This expansion into the European market further enhances the drug's revenue potential[4].

Challenges and Future Directions

While futibatinib has shown promising results, there are challenges to consider. The drug's long-term efficacy and safety will need to be confirmed through ongoing and future trials. Additionally, managing adverse events such as hyperphosphatemia, which was the most common adverse event, will be crucial for maintaining patient compliance and quality of life[2][5].

Future directions include elucidating mechanisms of resistance and exploring combination therapy approaches to further enhance the drug's efficacy and expand its indications to other FGFR-altered cancers[5].

Key Takeaways

• Regulatory Approvals: Futibatinib received FDA accelerated approval and EMA conditional marketing authorization.
• Clinical Efficacy: Demonstrated a 42% ORR and a median duration of response of 9.7 months in iCCA patients with FGFR2 alterations.
• Market Impact: Differentiates itself with a covalent binding mechanism and low susceptibility to acquired resistance.
• Financial Projections: Expected to generate significant revenue due to its efficacy, safety profile, and market penetration.
• Global Expansion: Approved in the U.S. and conditionally approved in Europe, with potential for further global expansion.

FAQs

Q: What is the primary indication for futibatinib? A: Futibatinib is primarily indicated for the treatment of adult patients with previously treated, unresectable, locally advanced or metastatic intrahepatic cholangiocarcinoma harboring FGFR2 gene fusions or other rearrangements.

Q: What is the mechanism of action of futibatinib? A: Futibatinib is a covalently binding FGFR1-4 inhibitor, which differentiates it from other FGFR inhibitors that show reversible binding.

Q: What were the key outcomes of the FOENIX-CCA2 clinical trial? A: The trial showed an ORR of 42%, a median duration of response of 9.7 months, and median progression-free survival and overall survival of 9.0 months and 21.7 months, respectively.

Q: How does futibatinib compare to other FGFR inhibitors? A: Futibatinib stands out due to its low susceptibility to acquired resistance and its ability to maintain patient quality of life, making it a preferred option for patients with FGFR2-altered tumors.

Q: What are the common adverse events associated with futibatinib? A: Common adverse events include nail toxicity, musculoskeletal pain, constipation, diarrhea, fatigue, and hyperphosphatemia, among others.

Cited Sources

1. FDA grants accelerated approval to futibatinib for cholangiocarcinoma. FDA.
2. Futibatinib for FGFR2-Rearranged Intrahepatic Cholangiocarcinoma. PubMed.
3. Taiho Oncology Announces Publication in The New England Journal of Medicine of Pivotal Data for Futibatinib in Previously Treated Patients with Metastatic Intrahepatic Cholangiocarcinoma. PR Newswire.
4. Futibatinib for the Treatment of Previously Treated, Unresectable, Locally Advanced or Metastatic Intrahepatic Cholangiocarcinoma with Fibroblast Growth Factor Receptor 2 (FGFR2) Gene Fusions or Other Rearrangements. Touch Oncology.
5. Futibatinib, an Irreversible FGFR1-4 Inhibitor for the Treatment of Advanced, Refractory Cancers. PubMed.