FRUZAQLA Listed on PBS for mCRC in Australia

Another treatment option for metastatic colorectal cancer (mCRC) is now available on the Pharmaceutical Benefits Scheme (PBS)

May 1, 2026

FRUZAQLA® (fruquintinib) has been listed on the PBS for people with mCRC who have been previously treated with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy, an anti-VEGF agent, and an anti-EGFR agent if appropriate.¹
The availability of FRUZAQLA on the PBS provides subsidised access to this nonchemotherapy oral medicine for eligible mCRC patients.¹

SYDNEY AUSTRALIA, 1 May 2026 - Takeda has welcomed the announcement that FRUZAQLA® (fruquintinib) has been listed on the PBS for people with colorectal cancer (CRC) that has spread to other parts of the body (metastatic), whose disease has continued to progress after two previous lines of therapy.¹

People with mCRC have had limited treatment options that prolong survival outside chemotherapy.¹ Up to 65% of patients with CRC will experience metastatic disease, whether at diagnosis or over the course of treatment.^2,3 In Australia, the five-year survival rate for people with mCRC is around 13%.⁴ Tragically, 5,235 lives were lost to mCRC in 2025.⁵

FRUZAQLA is used in Australia to treat adults with CRC that has spread to other parts of the body (metastatic). It is used when other treatments have not worked or when other treatments are not suitable.⁶

“Takeda is committed to bringing forward new treatment options in areas where patients have historically had limited choices,” said Dave Pearce, General Manager, Oceania at Takeda. “The PBS listing of FRUZAQLA reflects our ongoing investment in oncology and our broader pipeline aimed at improving outcomes for people living with cancer.”

“I welcome the Australian Government’s decision to list FRUZAQLA on the PBS for eligible patients with mCRC as it broadens choices for patients who have failed at least two previous lines of therapy.” said Professor Niall Tebbutt, Director Medical Oncology, Austin Health.

Treatment options should be discussed with a patient’s specialist. FRUZAQLA is an Australian registered prescription medicine and can only be prescribed by a doctor experienced in cancer treatment.⁶

For more information about FRUZAQLA, refer to the Consumer Medicine Information (CMI) at https://www.ebs.tga.gov.au/ebs/picmi/picmirepository.nsf/pdf?OpenAgent&id=CP-2024-CMI-02665-1

Side effects: All medicines can have side effects. The most common side effects with FRUZAQLA include fatigue, high blood pressure, abdominal pain, inflamed and sore mouth, and diarrhoea.7

Contraindications: FRUZAQLA is contraindicated in individuals with known hypersensitivity to fruquintinib or any components of the formulation.7 Precautions: Includes hypertension, haemorrhage, infections, gastrointestinal (GI) perforation, hepatotoxicity, proteinuria, palmar-plantar erythrodysaesthesia syndrome (PPES), posterior reversible encephalopathy syndrome (PRES), impaired wound healing, arterial thromboembolic events, use in the elderly, paediatric use.7 Interactions: Some medicines may interfere with FRUZAQLA and affect how it works. These include rifampicin (a medicine used to treat tuberculosis or other infections) and efavirenz (a medicine used to treat HIV-1 infection).6 Please refer to the Consumer Medicine Information (CMI) for more information.6

Disclosure: Professor Niall Tebbutt has provided paid consulting advice to Takeda, including the Takeda colorectal cancer Advisory Board. In relation to this Takeda media announcement, no compensation was provided to Professor Tebbutt, and the opinions expressed are his own. Professor Tebbutt has been briefed by Takeda on the approved use of this product.

PBS INFORMATION: This product is listed on the PBS. Authority required. Refer to PBS schedule for full authority information.

This medicine is subject to additional monitoring. This will allow quick identification of new safety information. Patients can help by reporting any side effects they may get. Patients can report side effects to their doctor, or directly at https://www.tga.gov.au/reportingproblems. Healthcare professionals are asked to report any suspected adverse events at https://www.tga.gov.au/reporting-problems.

Side effects can also be reported to Takeda: [email protected].

About Takeda

Takeda is focused on creating better health for people and a brighter future for the world. We aim to discover and deliver life-transforming treatments in our core therapeutic and business areas, including gastrointestinal and inflammation, rare diseases, plasma-derived therapies, oncology, neuroscience and vaccines. Together with our partners, we aim to improve the patient experience and advance a new frontier of treatment options through our dynamic and diverse pipeline. As a leading valuesbased, R&D-driven biopharmaceutical company headquartered in Japan, we are guided by our commitment to patients, our people, and the planet. Our employees in approximately 80 countries and regions are driven by our purpose and are grounded in the values that have defined us for more than two centuries. For more information, visit www.takeda.com.

For media enquiries, please contact:

Tanya West [email protected]

+61 406 907 845

Jessica Lewington [email protected]

+61 451 912 598

Important Notice

For the purposes of this notice, “press release” means this document, any oral presentation, any question and answer session and any written or oral material discussed or distributed by Takeda Pharmaceutical Company Limited (“Takeda”) regarding this release. This press release (including any oral briefing and any question-and-answer in connection with it) is not intended to, and does not constitute, represent or form part of any offer, invitation or solicitation of any offer to purchase, otherwise acquire, subscribe for, exchange, sell or otherwise dispose of, any securities or the solicitation of any vote or approval in any jurisdiction. No shares or other securities are being offered to the public by means of this press release. No offering of securities shall be made in the United States except pursuant to registration under the U.S. Securities Act of 1933, as amended, or an exemption therefrom. This press release is being given (together with any further information which may be provided to the recipient) on the condition that it is for use by the recipient for information purposes only (and not for the evaluation of any investment, acquisition, disposal or any other transaction). Any failure to comply with these restrictions may constitute a violation of applicable securities laws. The companies in which Takeda directly and indirectly owns investments are separate entities. In this press release, “Takeda” is sometimes used for convenience where references are made to Takeda and its subsidiaries in general. Likewise, the words “we”, “us” and “our” are also used to refer to subsidiaries in general or to those who work for them. These expressions are also used where no useful purpose is served by identifying the particular company or companies.

Abbreviations

EGFR: endothelial growth factor receptor; mCRC: metastatic colorectal cancer; PBS: Pharmaceutical Benefits Scheme; VEGFR, vascular endothelial growth factor receptor.

References

Pharmaceutical Benefits Scheme (PBS). Available at: https://www.pbs.gov.au.
Cervantes A et al. Ann Oncol 2023;34(1):10–32.
Vatandoust et al. World J Gastroenterol. 2015;21(41):11767–11776.
AIHW. National Bowel Cancer Screening Program monitoring report 2025. Available at: https://www.aihw.gov.au/reports/cancer-screening/nbcsp-monitoring2025/contents/introduction/bowel-cancer-facts. [Accessed 22 April 2026].
Cancer Australia. Bowel cancer (Colorectal cancer) in Australia statistics. Available at: https://www.canceraustralia.gov.au/cancer-types/bowel-cancer/bowel-cancer-colorectal-canceraustralia-statistics. [Accessed 22 April 2026].
FRUZAQLA Approved Consumer Medicine Information.
FRUZAQLA Approved Product Information.
TAKEDA® and the TAKEDA logo® are registered trademarks of Takeda Pharmaceutical Company Limited. FRUZAQLA and the FRUZAQLA Logo are registered trademarks of HUTCHMED Group Enterprises Limited, used under license. © 2026 Takeda Pharmaceuticals Australia Pty Limited, Sydney NSW 2000 ABN 71 095 610 870

Telephone: 1800 012 612. Email: [email protected]. Date of Preparation: April 2026. [C-APROM/AU/FRZ/0032].

* FRUZAQLA® (fruquintinib) has been listed on the PBS for people with mCRC who have been previously treated with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy, an anti-VEGF agent, and an anti-EGFR agent if appropriate.1 * The availability of FRUZAQLA on the PBS provides subsidised access to this nonchemotherapy oral medicine for eligible mCRC patients.1 **SYDNEY AUSTRALIA, 1 May 2026** - Takeda has welcomed the announcement that FRUZAQLA® (fruquintinib) has been listed on the PBS for people with colorectal cancer (CRC) that has spread to other parts of the body (metastatic), whose disease has continued to progress after two previous lines of therapy.1 People with mCRC have had limited treatment options that prolong survival outside chemotherapy.1 Up to 65% of patients with CRC will experience metastatic disease, whether at diagnosis or over the course of treatment.2,3 In Australia, the five-year survival rate for people with mCRC is around 13%.4 Tragically, 5,235 lives were lost to mCRC in 2025.5 FRUZAQLA is used in Australia to treat adults with CRC that has spread to other parts of the body (metastatic). It is used when other treatments have not worked or when other treatments are not suitable.6 “Takeda is committed to bringing forward new treatment options in areas where patients have historically had limited choices,” said Dave Pearce, General Manager, Oceania at Takeda. “The PBS listing of FRUZAQLA reflects our ongoing investment in oncology and our broader pipeline aimed at improving outcomes for people living with cancer.” “I welcome the Australian Government’s decision to list FRUZAQLA on the PBS for eligible patients with mCRC as it broadens choices for patients who have failed at least two previous lines of therapy.” said Professor Niall Tebbutt, Director Medical Oncology, Austin Health. Treatment options should be discussed with a patient’s specialist. FRUZAQLA is an Australian registered prescription medicine and can only be prescribed by a doctor experienced in cancer treatment.6 For more information about FRUZAQLA, refer to the Consumer Medicine Information (CMI) at [https://www.ebs.tga.gov.au/ebs/picmi/picmirepository.nsf/pdf?OpenAgent&id=CP-2024-CMI-02665-1](https://www.ebs.tga.gov.au/ebs/picmi/picmirepository.nsf/pdf?OpenAgent&id=CP-2024-CMI-02665-1) **Side effects:** All medicines can have side effects. The most common side effects with FRUZAQLA include fatigue, high blood pressure, abdominal pain, inflamed and sore mouth, and diarrhoea.7 **Contraindications:** FRUZAQLA is contraindicated in individuals with known hypersensitivity to fruquintinib or any components of the formulation.7 Precautions: Includes hypertension, haemorrhage, infections, gastrointestinal (GI) perforation, hepatotoxicity, proteinuria, palmar-plantar erythrodysaesthesia syndrome (PPES), posterior reversible encephalopathy syndrome (PRES), impaired wound healing, arterial thromboembolic events, use in the elderly, paediatric use.7 Interactions: Some medicines may interfere with FRUZAQLA and affect how it works. These include rifampicin (a medicine used to treat tuberculosis or other infections) and efavirenz (a medicine used to treat HIV-1 infection).6 Please refer to the Consumer Medicine Information (CMI) for more information.6 **Disclosure:** Professor Niall Tebbutt has provided paid consulting advice to Takeda, including the Takeda colorectal cancer Advisory Board. In relation to this Takeda media announcement, no compensation was provided to Professor Tebbutt, and the opinions expressed are his own. Professor Tebbutt has been briefed by Takeda on the approved use of this product. **PBS INFORMATION:** This product is listed on the PBS. Authority required. Refer to PBS schedule for full authority information. This medicine is subject to additional monitoring. This will allow quick identification of new safety information. Patients can help by reporting any side effects they may get. Patients can report side effects to their doctor, or directly at [https://www.tga.gov.au/reportingproblems](https://www.tga.gov.au/reportingproblems). Healthcare professionals are asked to report any suspected adverse events at [https://www.tga.gov.au/reporting-problems](https://www.tga.gov.au/reporting-problems). Side effects can also be reported to Takeda: [[email protected]](mailto:[email protected]). ## About Takeda Takeda is focused on creating better health for people and a brighter future for the world. We aim to discover and deliver life-transforming treatments in our core therapeutic and business areas, including gastrointestinal and inflammation, rare diseases, plasma-derived therapies, oncology, neuroscience and vaccines. Together with our partners, we aim to improve the patient experience and advance a new frontier of treatment options through our dynamic and diverse pipeline. As a leading valuesbased, R&D-driven biopharmaceutical company headquartered in Japan, we are guided by our commitment to patients, our people, and the planet. Our employees in approximately 80 countries and regions are driven by our purpose and are grounded in the values that have defined us for more than two centuries. For more information, visit [www.takeda.com](https://www.takeda.com). **For media enquiries, please contact:** Tanya West [[email protected]](mailto:[email protected]) +61 406 907 845 Jessica Lewington [[email protected]](mailto:[email protected]) +61 451 912 598 ## Important Notice For the purposes of this notice, “press release” means this document, any oral presentation, any question and answer session and any written or oral material discussed or distributed by Takeda Pharmaceutical Company Limited (“Takeda”) regarding this release. This press release (including any oral briefing and any question-and-answer in connection with it) is not intended to, and does not constitute, represent or form part of any offer, invitation or solicitation of any offer to purchase, otherwise acquire, subscribe for, exchange, sell or otherwise dispose of, any securities or the solicitation of any vote or approval in any jurisdiction. No shares or other securities are being offered to the public by means of this press release. No offering of securities shall be made in the United States except pursuant to registration under the U.S. Securities Act of 1933, as amended, or an exemption therefrom. This press release is being given (together with any further information which may be provided to the recipient) on the condition that it is for use by the recipient for information purposes only (and not for the evaluation of any investment, acquisition, disposal or any other transaction). Any failure to comply with these restrictions may constitute a violation of applicable securities laws. The companies in which Takeda directly and indirectly owns investments are separate entities. In this press release, “Takeda” is sometimes used for convenience where references are made to Takeda and its subsidiaries in general. Likewise, the words “we”, “us” and “our” are also used to refer to subsidiaries in general or to those who work for them. These expressions are also used where no useful purpose is served by identifying the particular company or companies. ## Abbreviations EGFR: endothelial growth factor receptor; mCRC: metastatic colorectal cancer; PBS: Pharmaceutical Benefits Scheme; VEGFR, vascular endothelial growth factor receptor. ## References 1. Pharmaceutical Benefits Scheme (PBS). Available at: [https://www.pbs.gov.au](https://www.pbs.gov.au). 2. Cervantes A et al. Ann Oncol 2023;34(1):10–32. 3. Vatandoust et al. World J Gastroenterol. 2015;21(41):11767–11776. 4. AIHW. National Bowel Cancer Screening Program monitoring report 2025. Available at: [https://www.aihw.gov.au/reports/cancer-screening/nbcsp-monitoring2025/contents/introduction/bowel-cancer-facts](https://www.aihw.gov.au/reports/cancer-screening/nbcsp-monitoring2025/contents/introduction/bowel-cancer-facts). [Accessed 22 April 2026]. 5. Cancer Australia. Bowel cancer (Colorectal cancer) in Australia statistics. Available at: [https://www.canceraustralia.gov.au/cancer-types/bowel-cancer/bowel-cancer-colorectal-canceraustralia-statistics](https://www.canceraustralia.gov.au/cancer-types/bowel-cancer/bowel-cancer-colorectal-canceraustralia-statistics). [Accessed 22 April 2026]. 6. FRUZAQLA Approved Consumer Medicine Information. 7. FRUZAQLA Approved Product Information. TAKEDA® and the TAKEDA logo® are registered trademarks of Takeda Pharmaceutical Company Limited. FRUZAQLA and the FRUZAQLA Logo are registered trademarks of HUTCHMED Group Enterprises Limited, used under license. © 2026 Takeda Pharmaceuticals Australia Pty Limited, Sydney NSW 2000 ABN 71 095 610 870 Telephone: 1800 012 612. Email: [[email protected]](mailto:[email protected]). Date of Preparation: April 2026. [C-APROM/AU/FRZ/0032].