Laboratoires Pierre Fabre announces the approval of BRAFTOVI® (encorafenib) in combination with MEKTOVI® (binimetinib) for the treatment of adult patients with advanced non-small cell lung cancer with a BRAFV600E mutation in Singapore

• New targeted treatment option now available in for adult patients with BRAF^V600E mutant advanced non-small cell lung cancer (NSCLC)
• Launch follows European approval based on results from the Phase II PHAROS trial, demonstrating meaningful clinical benefit to patients with a high objective response rate (ORR)^1,2

SINGAPORE, Nov. 3, 2026 /PRNewswire/ — Laboratoires Pierre Fabre Singapore is delighted to announce the access for patients to BRAFTOVI^® (encorafenib) in combination with MEKTOVI^® (binimetinib) for the treatment of adult patients with advanced NSCLC with a BRAF^V600E mutation.

It follows the European Commission (EC) approval that was based on the results from the Phase II PHAROS trial, a global, open-label, multicentre, non-randomised trial to determine the efficacy and safety of BRAFTOVI^® + MEKTOVI^® in 98 patients from 56 study centres across 5 countries.^1,2

Lung cancer is the leading cause of cancer-related deaths, with 1,278 deaths in Singapore annually, and 1,942 new cases diagnosed every year whereby 1-2% of NSCLC are BRAF^V600E mutant.^3,4

"We are delighted to be able to bring BRAFTOVI^® + MEKTOVI^® to NSCLC patients with a BRAF^V600E mutation in Singapore. This approval from Health Sciences Authority (HSA) is a significant milestone as BRAFTOVI^® + MEKTOVI^® will give patients the option of an additional effective targeted therapy. This is a further demonstration of our commitment to addressing the most critical needs in cancer care today through the delivery of clinically meaningful treatments," said Jairo Pardey, General Manager Laboratoires Pierre Fabre, Singapore.

About the Health Sciences Authority (HSA) approval

The BRAFTOVI^® + MEKTOVI^® Singapore approved prescribing information includes results from the Phase II PHAROS trial.^1,5,6 At primary analysis (cut-off date: September 22, 2022), the primary endpoint of the trial (objective response rate [ORR] determined by independent radiology review [IRR]) was met. In the treatment-naïve population (n=59), the ORR was 75% (95% CI: 62, 85), including 15% complete responses (CRs) and 59% partial responses (PRs).^1,5,6 Updated results with an additional 10-month follow-up showed that 64% of patients maintained a response for at least 12 months, with a median duration of response (mDOR) per IRR of 40 months (95% CI: 23.1, not estimable [NE]). ^5,6* For those patients who had received prior therapy (n=39), the ORR by IRR was 46% (95% CI: 30, 63), including 10% CRs and 36% PRs at primary analysis.^1,5,6 Updated results with an additional 10-month follow-up showed that 44% of patients maintained a response for at least 12 months with a mDOR of 16.7 months (95% CI: 7.4, NE).^5,6*

The most common treatment-related adverse events (TRAEs ≥20%) were nausea (50%), diarrhoea (43%), fatigue (32%), and vomiting (29%). Treatment-related serious AEs occurred in 14% of patients, with the most common being colitis (3%).^1,6 One grade 5 TRAE of intracranial haemorrhage was reported.¹

*Results for mDOR from a sensitivity analysis considering new anti-cancer therapy as an event in addition to progression and death are 23.1 months in treatment-naïve patients (14.8, NE) and 12.0 months (6.3, NE) in previously treated patients.⁵

About PHAROS

PHAROS (NCT03915951) is an on-going open-label, single arm, multicentre, non-randomised Phase II trial to determine the efficacy and safety of BRAFTOVI^® (encorafenib 450 mg QD) in combination with MEKTOVI^® (binimetinib 45 mg BID) in 98 patients with advanced NSCLC with a BRAF^V600E mutation who are either treatment-naive or who have been previously treated with platinum-based chemotherapy and/or anti-PD-1/PD-L1 inhibitor therapy. Mutations were identified using next-generation sequencing or polymerase chain reaction tests. The primary endpoint is confirmed ORR per RECIST v1.1, by independent radiology review (IRR); secondary objectives comprise additional efficacy endpoints including duration of response (DOR), progression-free survival, and overall survival as well as safety. The trial is being conducted across 56 sites in: Italy, the Netherlands, South Korea, Spain, and the U.S.

The PHAROS trial is sponsored by Pfizer Inc. and conducted with support from Laboratoires Pierre Fabre.

About BRAF^V600E mutant advanced Non-Small Cell Lung Cancer (NSCLC)

Lung cancer is the leading cause of cancer-related deaths, with over 1.8 million deaths worldwide annually.⁷ Globally, lung cancers make up 12.4% of all cancers with over 2.4 million new cases every year.⁸ Non-Small Cell Lung Cancer (NSCLC) accounts for approximately 80-85% of all lung cancers.^9.10

Currently, it is estimated that up to 69% of advanced NSCLC patients have druggable mutations in numerous genes.¹¹

BRAF^V600E mutations occur in approximately 1-2% of NSCLC cases.⁴ It stimulates tumour cell growth and proliferation by altering the MAP kinase (MAPK) signalling pathway. Inhibition of both BRAF and the downstream mitogen activated protein kinase (MEK) pathway has been shown to improve response rates in patients compared with BRAF inhibition alone.^1,12

Precision medicine has made great progress in the treatment of lung cancer for NSCLC patients with genetic alterations, such as BRAF^V600E mutations, that can be detected using biomarker tests.^13,14 Advances in targeted therapy and more widespread use of biomarker testing have been associated with significant improvements in population-level NSCLC mortality in recent years.¹⁵

About BRAFTOVI^® + MEKTOVI^®

BRAFTOVI^® (encorafenib), a potent and highly selective BRAF inhibitor with a distinct pharmacological profile compared with other BRAF inhibitors, and MEKTOVI^® (binimetinib), a potent and selective MEK inhibitor, inhibit kinases in the MAPK pathway – which is constitutively activated in BRAF^V600E mutant NSCLC – resulting in clinically relevant anti-tumour activity.

Uncontrolled activation of this pathway has been shown to occur in many cancers, including melanoma, CRC, and NSCLC.^1,16

In 2018, the European Commission (EC) approved BRAFTOVI^® + MEKTOVI^® for adult patients with unresectable or metastatic melanoma with a BRAF^V600 mutation. The approval was based on results from the randomised, active-controlled, open-label, multicentre Phase III COLUMBUS trial.

In 2020, the EC approved BRAFTOVI^® in combination with cetuximab, for the treatment of adults with metastatic CRC with a BRAF^V600E mutation who have received prior systemic therapy. The approval was based on results from the randomised, active-controlled, open-label, multicentre Phase III BEACON CRC trial.

Pfizer has exclusive rights to commercialise BRAFTOVI^® and MEKTOVI^® in the U.S., Canada, and all countries in the Latin American, African, and Middle Eastern regions; Ono Pharmaceutical Co., Ltd. has exclusive rights to commercialise both products in Japan and South Korea; Medison has exclusive rights in Israel; and Laboratoires Pierre Fabre has exclusive rights in all other countries, including Europe and Asia-Pacific.

The full product and safety information for the use of BRAFTOVI^® and MEKTOVI^® are outlined in the Product Information (PI) published in the Health Sciences Authority (HSA) database and can be accessed here.

About Laboratoires Pierre Fabre

Laboratoires Pierre Fabre is one of Europe’s leading pharmaceutical laboratories and the world’s second-largest dermo-cosmetics company. Its Pharma activity covers 5 main therapeutic fields: oncology, dermatology, rare diseases, primary care and family health care. The Dermo-cosmetics & Personal Care portfolio includes international brands such as Eau Thermale Avène, Dexeryl, Ducray, Klorane, A-Derma, René Furterer, Même Cosmetics, Darrow and Elgydium.

For over 40 years, Laboratoires Pierre Fabre has established itself as an international player in oncology, mastering the entire value chain from R&D to marketing. Its portfolio of oncology specialties covers colorectal, breast, lung and skin cancers, as well as certain hematologic malignancies and precancerous dermatological conditions such as actinic keratosis. In 2025, Laboratoires Pierre Fabre’ revenues in oncology came to 565 million euros, 71% of which were generated by international sales, out of a total sales figure of 3.2 billion euros.

Based in southwest France since its creation, Laboratoires Pierre Fabre manufactures nearly 90% of its products in France and employs 10,000 people worldwide. In 2025, its R&D budget amounted to 250 million euros, of which 67% is allocated to targeted therapies in oncology with 10 research and development programs underway.

Laboratoires Pierre Fabre’ majority shareholder (86%) is an eponymous humanitarian Foundation. Employees constitute the company’s other shareholder. This capital structure guarantees the company’s independence, long-term vision and contribution to the common good. The dividends paid to the Pierre Fabre Foundation contribute to 43 healthcare-access programs deployed in 26 of the least developed countries in the world.

Laboratoires Pierre Fabre’ CSR policy has been assessed by AFNOR Certification and has been awarded the "Exemplary" level of its CSR label (ISO 26 000 standard for sustainable development).

For more information, visit www.pierre-fabre.com,  @Laboratoires Pierre Fabre, @Pierre Fabre Oncology

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