🇲🇾 Cancer in Malaysia

The Malaysia National Cancer Registry Report 2017-2021, the registry's third five-year report (published December 2025, expanding an e-Summary of July 2024), counts 77,692 cancers in men and 91,131 in women among Malaysian citizens and residents, at age-standardised rates of 107.3 and 120.8 per 100,000. The cumulative risk before age 75 was 11.9% in men and 12.7% in women (1 in 8 for both, against 1 in 10 men and 1 in 9 women in 2012 to 2016). Against 2012 to 2016 the all-sites rate rose by 21.2 per 100,000 in men and 19.2 in women. The ten commonest cancers were breast (29,719, 17.6%), colorectal (23,871), lung (17,028), lymphoma (8,793), liver (8,256), prostate (6,441), leukaemia (6,265), nasopharynx (5,186), corpus uteri (5,087) and ovary (4,714). Rates rose most for colorectal, liver, lung and prostate cancer in men and breast, colorectal, uterine and lung cancer in women; nasopharyngeal and bladder cancer fell in men and cervical cancer fell in women. The registry attributes the rise to both a true increase and better case-finding.

The Ministry of Health started population-based registration in 1993 with regional registries and made it nationwide in 2007, when all 15 states and federal territories set up their own. Paper NCR-02 forms entered into IARC's CanReg5 software were replaced from 2018 by the M2b online module of the Malaysian Health Data Warehouse, which checks each patient's identity card number with the National Registration Department. A Director General of Health circular in April 2020 made notification mandatory for government doctors and encouraged it in private facilities. For 2017 to 2021, 64.4% of cases came from notifications, 16.4% from pathology records, 13.7% from hospital discharge records and 5.5% from death records alone; about 5% came from university hospitals and 10% from private hospitals. Quality indicators: 87.6% of cases were morphologically verified, 5.3% (8,904) were death certificate only, and 2.4% had an ill-defined primary site. Staging, coded to AJCC TNM, was recorded for only 45.1% of cases.

Staging was recorded for 76,125 cases (45.1%), against 52.8% in 2012 to 2016. Among them 15.5% were stage I, 19.7% stage II, 24.6% stage III and 40.2% stage IV; stage IV fell slightly from 40.9% while stage III rose from 22.8%. By site (Table 15 and Table 17), 49.7% of staged breast cancers were stage III or IV, 73.7% of colorectal cancers in men and 73.5% in women, 76.2% of nasopharyngeal cancers in men, 63.3% of prostate cancers, 46.6% of cervical cancers, and 95.5% of lung cancers in men and 94.7% in women, of which 78.3% and 82.3% were stage IV. The Minister's message notes that more than half of breast, colorectal, lung and prostate cancers are still detected at stage III or IV. The registry's survival study, MySCan, found that stage IV breast cancer carried 7.52 times the risk of death of stage I, for cancers diagnosed in 2007 to 2011.

Age-standardised rates in 2017 to 2021 were 147.9 per 100,000 in Chinese men and 141.7 in Chinese women, 98.2 and 139.7 in Indians, 84.4 and 105.9 in Malays, and 87.4 and 99.7 in Other Bumiputera. The lifetime risk of breast cancer was 1 in 17 for Indian women, 1 in 19 for Chinese, 1 in 26 for Malay and 1 in 45 for Other Bumiputera women. Nasopharyngeal cancer, 74.8% of it in men, had a lifetime risk of 1 in 100 for Chinese and Other Bumiputera men against 1 in 167 for all men, and its highest female risk was among Other Bumiputera women (1 in 250). Cervical cancer was most common among Other Bumiputera women (lifetime risk 1 in 100) and fell nationally from an age-standardised 7.6 per 100,000 in 2007 to 2011 to 6.0 in 2017 to 2021. Liver cancer cases doubled from 4,033 to 8,256 between the two periods, with the highest rates among Chinese men (12.0 per 100,000).

The ministry's schedule of charges under the Fees (Medical) Order 1982, as amended in 2017, sets RM1 per visit to a general outpatient department or polyclinic, including investigations; for specialist clinics, the first visit on referral from a government medical officer or specialist is free and each follow-up costs RM5, including investigations. Government employees are exempt. Surgery in a third-class ward costs RM10 to RM200 by type of operation, and the maximum charge for a third-class patient is RM500 per admission. In a reply to the Dewan Rakyat on 19 May 2016 the Minister of Health gave chemotherapy charges of RM200 per treatment in first class, RM100 in second and RM50 in third, within the same RM500 cap, and said citizens aged 60 and over pay no RM5 specialist registration charge and get 50% off third-class charges. He said the ministry spent RM253.4 million that year on medicines for radiotherapy and oncology, and that patients are referred to the Medical Welfare Fund for medicines and equipment hospitals do not supply, and Muslim patients to the zakat boards. Whether these chemotherapy charges are still current was not verified.

The National Strategic Plan for Cancer Control Programme 2021-2025 lists the public centres offering both systemic treatment and radiotherapy: Hospital Kuala Lumpur, Institut Kanser Negara, Hospital Pulau Pinang, Hospital Sultan Ismail in Johor Bahru, Hospital Umum Sarawak and Hospital Wanita dan Kanak-Kanak Sabah under the ministry, and the University Malaya Medical Centre, Hospital Canselor Tuanku Muhriz UKM and Hospital Universiti Sains Malaysia. It names long waits for curative radiotherapy, access to formulary drugs and access to oncologists as problems, and notes RM500 million announced in 2018 for a Northern Oncology Centre. In a written parliamentary reply reported on 6 November 2024, the ministry said chemotherapy would be available in 41 hospitals by 2025 and adult oncology at eight centres; that resident oncologists would be placed at Hospital Tengku Ampuan Afzan, Hospital Sultanah Bahiyah, Hospital Pakar Sultanah Fatimah, Tawau Hospital, Hospital Sultanah Nora Ismail and Duchess of Kent Hospital from 2026 to 2029; that the Sarawak Cancer Centre and the Northern Region Cancer Centre in Kedah were in pre-implementation; and that radiotherapy would be widened through its Hospital Services Outsourcing Programme.

The National Strategic Plan for Cancer Control Programme 2021-2025 cites the ASEAN Costs in Oncology (ACTION) study for its Malaysian figure. The study's abstract gives pooled results for eight countries: of 9,513 adults with a new cancer diagnosis, 29% had died a year later and 48% had faced costs above 30% of household income, and people without insurance were more likely to face both. PeKa Sihat, the Skim Peduli Kesihatan untuk Kumpulan B40 run for the ministry by ProtectHealth since 15 April 2019, covers recipients of the Sumbangan Tunai Rahmah cash transfer and their spouses aged 40 and over, automatically and without registration; after a health screening at a clinic it offers medical equipment worth up to RM20,000, the RM1,000 cancer treatment incentive (RM300 when treatment starts and RM700 when it is completed in a ministry hospital) and a transport allowance of up to RM500 in the peninsula or RM1,000 in Sabah, Sarawak and Labuan. The plan lists screening by iFOBT among the targets for PeKa B40 by 2025.

The formulary guidelines (fourth edition, 2025, in Malay) say the formulary lists medicines that are registered with the Drug Control Authority, treat diseases with a high burden, and have advantages in quality, efficacy, safety and cost-effectiveness. In January 2025 it held 1,650 preparations of 864 chemical entities, against 994 preparations of 596 entities in the first list of 1983. Each entry carries a prescriber category: A* means consultants or specialists for specific indications only, A any consultant or specialist, A/KK also family medicine specialists, and B, C and C+ widen to medical officers and paramedics. The formulary does not necessarily list every registered indication. Special approval (kelulusan khas) is needed for a registered medicine not on the list, a listed medicine for an unlisted indication, or an unregistered medicine, and is considered only when listed treatment failed or was not tolerated, for a life-saving medicine or a specific indication with no listed alternative, for epidemics, or for orphan medicines. Prices declared when a medicine is listed are valid for two years.

The Guidelines for Submission of Dossier for Listing into the Ministry of Health Medicines Formulary (first edition, October 2015) require a letter of intent, answered within 5 working days, and a full dossier within 6 months. Eligibility: registration with the Drug Control Authority for at least 12 months, the indication approved in Malaysia, listing on a reimbursement list or national formulary in at least two countries, 12 months of use in Malaysia with an updated safety report, therapeutic advantage supported by evidence, and support from two consultants or specialists in different ministry institutions. Dossiers are evaluated by the formulary secretariat with its pharmacoeconomics unit and committees, and need at least 14 weeks before a panel meeting; panels were planned for March, July and November. A rejected medicine can be resubmitted after 6 months with new clinical evidence or a significant price reduction, and after 12 months if rejected again. The 2025 guidelines refer to a 2024 edition of these rules, which OnCo did not read. The cancer plan records that gefitinib and afatinib were listed for EGFR-mutated metastatic lung cancer after prices were negotiated under value-based medicine.

MaHTAS, in the Medical Development Division, describes itself as the ministry's custodian of evidence- and value-based medicine. It assesses drugs, biologics, devices, procedures and programmes for effectiveness, safety, cost-effectiveness and organisational, social and ethical issues; coordinates clinical practice guidelines; and runs horizon scanning. The cancer plan reports that the 2017 assessment found low-dose CT highly sensitive but not very specific in high-risk people and recommended it for research use only; a ministry lung screening study at 14 hospitals with industry support was stopped for poor public response and budget, while Institut Kanser Negara's radiology department kept low-dose CT screening as a routine service. The plan describes value-based medicine, a health economic evaluation from several perspectives before a therapy is approved for ministry hospitals, as the ministry's response to the cost of precision medicine. A separate positive list of cancer medicines is now being built for private insurance; see below.

NPRA's Drug Registration Guidance Document (third edition, 12th revision, July 2026) sets 245 working days for a new chemical entity, including consultation with local clinical specialists, and 210 for a hybrid product. Its Facilitated Registration Pathway began with Directive No. 7 of 27 March 2019, relying on the EMA and US FDA, with an abbreviated review of 120 working days and a verification review of 90. Revision 1, agreed by the Drug Control Authority at its 390th meeting on 3 November 2023 and in force from 1 January 2024, added Health Canada, Japan's PMDA, Swissmedic, Australia's TGA and the UK MHRA, cut the abbreviated review to 90 working days, set 30 working days for verification of products assessed through the ASEAN Joint Assessment, extended the window for applying after the reference approval from 2 to 3 years, and brought in generics and cell and gene therapies. NPRA joined the WHO collaborative registration procedures for prequalified products on 9 January 2020 and for products of stringent authorities on 2 June 2022. The pilot announced on 7 May 2026, from 2 May 2026, accepts products identical to those approved by the US FDA or by the EMA's centralised procedure, submitted within three months of that approval, with an administrative timeline of 60 working days from payment after screening.

The 2020 study counted 25 new active substances and one biosimilar approved in 2017: a median of 515 days in all, of which 135 days were queuing before scientific assessment began; the assessment took a median of 279 days, 166 of them NPRA's and 131 the applicant's, with up to six review cycles and 65% of applications needing four or five. NPRA proposed starting assessment within 100 days, capping review cycles at five and limiting applicant responses to six months. The 2025 study of 24 new active substances approved in 2019 found the median had fallen to 399 calendar days, with a shorter wait before assessment. Both use the OpERA method of the Centre for Innovation in Regulatory Science and were written with NPRA staff. NPRA's client charter for 2016 reported 93 of 94 new drug and biologic applications (98.9%) evaluated within the 245-working-day target; that target is set in working days, while the two studies count calendar days including the applicant's time, so the figures are not comparable. Times under the reliance routes since 2024 have not been published in a form OnCo found.

The National Strategic Plan for Cancer Control Programme 2021-2025 sets out the policies. Breast: clinical breast examination every three years from 20 to 39 and every year from 40; yearly mammography for women of 40 and over with risk factors, and every two years for women aged 50 to 74. Colorectal: an immunological faecal occult blood test (iFOBT) every two years for people aged 50 to 75 without symptoms, with colonoscopy if positive. Cervical: HPV testing on a vaginal sample, taken by the woman herself or by a health worker, for sexually active women aged 30 to 65, repeated every five years after a negative result. Oral: examination from age 18 for people with high-risk habits or communities, which the plan names as Indian communities on rubber and oil palm estates in the peninsula and Other Bumiputera in Sabah and Sarawak. There is no national lung programme. The plan's colorectal target was to raise screening coverage from 10.8% (National Health and Morbidity Survey 2019) to 30% in the 2023 survey, adding iFOBT to the PeKa B40 and Social Security Organisation health screenings by 2025.

The cancer plan describes the HPV test as more sensitive than the Pap smear and gives the phases: Kuala Lumpur and Putrajaya, Kedah and Kelantan in 2019; Negeri Sembilan, Selangor, Penang and Sarawak in 2020; Terengganu, Johor and Melaka in 2021; Perak, Pahang, Perlis and Sabah in 2022; nationwide by 2024 or 2025. Its targets were 40% of women aged 30 to 65 screened by 2025 and a gynaecologist's review within two weeks of a positive result. The Minister of Health's message in the registry report credits sustained screening for the fall in cervical cancer, whose age-standardised rate went from 7.6 per 100,000 in 2007 to 2011 to 6.0 in 2017 to 2021, and notes that the effect of the HPV vaccination programme introduced in 2010 will show as vaccinated girls reach adulthood. Of cervical cancers with a stage in 2017 to 2021, 53.4% were found at stage I or II. Whether the 40% coverage target was met was not found; see the gaps.

The LEDANG trial (NCT07050043), registered on ClinicalTrials.gov by its sponsor-investigator, a consultant respiratory physician at Hospital Sultanah Bahiyah, Kedah, plans to randomise 123 patients 2 to 1 between six-weekly nivolumab 40 mg plus four to six cycles of platinum-based chemotherapy chosen by local practice and the same chemotherapy alone, to test superiority and safety. It started on 19 May 2025, is recruiting at one site in Malaysia, and lists a Ministry of Health grant reference; primary completion is estimated for 31 December 2030. It is one of four cancer trials in OnCo's records that list Malaysia as their only country, with a Ministry of Health trial of Foscan photodynamic therapy against brachytherapy for recurrent nasopharyngeal cancer (NCT01086488), a phase 2 trial of pre-operative artesunate in colorectal cancer (NCT07095309) and a phase 2/3 trial of the antibody PRL3-zumab in solid tumours (NCT07290088).

ProtectHealth, the Ministry of Health's not-for-profit financing company, released the tender for the Development and Governance of a Cancer Drug List for the Base Medical Health Insurance and Takaful (MHIT) Product on 3 April 2026, with a six-month contract planned for May to November 2026. The consultant is to review every cancer medicine registered by the Drug Control Authority, draw on the Medicines Formulary, its dossier concepts and the clinical practice guidelines, require cost-effectiveness or budget impact analysis from a Malaysian payer perspective for new listings, define cost-sharing categories, co-payments and coverage caps, benchmark private-sector prices and supply-chain mark-ups against other countries, and design referral pathways to ministry oncology services when cover runs out or a co-payment cannot be met. The deck describes the list as the possible foundation of a future national reimbursement framework, extensible to diagnosis-related group payments.

The registry covers 13 states and 3 federal territories. Notifications are made, since 2018, through the M2b module of the Malaysian Health Data Warehouse, a repository operational since August 2016 that pools records from government, private, university and military hospitals and clinics; the system verifies each patient's identity card number with the National Registration Department before the case enters the database. Cases are coded to ICD-10 and ICD-O-3.2, checked with IARC's software and assessed against the Cancer Incidence in Five Continents validity indicators. Its reports give every major cancer by state and by the four main ethnic groups, which is how the registry shows that nasopharyngeal and cervical cancer are commonest among Other Bumiputera, and that Kelantan's all-cancer rate in women (91.4 per 100,000) is about half that of Johor (184.6). IARC's own estimate for Malaysia still describes its source as a subnational registry.

Counted from ClinicalTrials.gov participation data in OnCo's graph on 4 November 2026: 171 trials list Malaysia among their countries, 123 of them phase 3, 22 phase 2, 13 phase 2/3, 12 phase 1/2 and 1 phase 1. OnCo's records mark 63 as recruiting and 72 as active. ClinicalTrials.gov names AstraZeneca as lead sponsor of 32, Merck Sharp & Dohme of 31, Janssen of 17 and Novartis of 14; non-small cell lung cancer is the first-listed cancer for 62, prostate for 14 and hormone receptor-positive breast cancer for 11. Lung trials with Malaysian sites include FLAURA, LAURA, MARIPOSA and LUX-Lung 3, and the liver and bile duct trials REFLECT, EMERALD-3 and KEYNOTE-966. Clinical Research Malaysia reports a 2024 partnership award with AstraZeneca that included a first-in-human study, and Roche's choice of Sarawak General Hospital for a global first-in-human trial. OnCo's OpenAlex snapshot of 8 September 2026 also records 2,618 ClinicalTrials.gov studies of all conditions with a site in Malaysia.

OpenAlex, counting works whose primary topic is oncology and counting a paper for every country among its authors' affiliations, gives Malaysia 398 works in 2021, 383 in 2022, 383 in 2023, 361 in 2024 and 499 in 2025, 2,024 in total, of which 1,445 are open access and 71 highly cited. The registry's Malaysian Study on Cancer Survival, published in 2018 for cancers diagnosed in 2007 to 2011, gave five-year relative survival of 82.3% for thyroid cancer, 73.0% for prostate, 70.6% for uterine, 66.8% for female breast and 56.8% for colon cancer, and 14% for pancreatic, 12.8% for liver and 11% for lung cancer; those are averages for people diagnosed 15 to 19 years ago, before most current treatments, and survival is higher at earlier stages. The registry's foreword names survival and mortality analyses as a priority.

The MaHTAS page on moh.gov.my returned 403; its own portal, mymahtas.moh.gov.my, was read instead. The National Strategic Plan for Cancer Control Programme 2021-2025 was read from the copy on the International Cancer Control Partnership portal. The outpatient and surgical charges come from a schedule hosted by the ministry's oral health programme (hq.moh.gov.my), which cites the 2017 amendment; the chemotherapy charges come from the minister's reply of 19 May 2016, and whether they have changed was not verified. Free Malaysia Today's report of 28 September 2025 and the New Straits Times report of February 2025 on cancer as a cause of death answered 403 and were not used. No plan for cancer control after 2025 was found from any source we could read.

The registry report gives 97,906 cancer deaths in 2017 to 2021 from the Department of Statistics but not by cancer site in the text read, and the Department's Statistics on Causes of Death were not read. The only national survival study found is MySCan (2018), for 2007 to 2011; the registry names survival analysis as a priority. The cancer plan sets coverage targets (40% for cervical screening by 2025; colorectal from 10.8% to 30%) but the National Health and Morbidity Survey 2023 results were not read, so whether they were met is not stated. The current (2024) edition of the formulary dossier guidelines was not read; the 2015 first edition was. No cost-effectiveness threshold for Malaysia was found. The registry's e-Summary of July 2024 gives some site figures that differ slightly from the full report (for staged cervical cancer, 47.1% at stage 3 or 4 against the full report's 46.6%); the full report's figures are used here.

The 245, 210, 90, 30 and 60 working-day figures are NPRA's targets. The measured medians (515 calendar days in 2017, 399 in 2019) cover all new active substances and predate the 2024 revision of the reliance pathway and the 2026 pilot. The 2015 dossier rules imply at least 12 months between registration and a company's application to list a medicine, plus at least 14 weeks to a panel meeting, but the formulary's circulars of amendments are on the ministry intranet and were not read, so no listing dates for cancer medicines are given. NPRA's client charter results after 2016 were not found.