Centre's ribociclib alternative claim sparks cancer treatment debate
The Centre has been telling the Kerala High Court that patients who cannot afford ribociclib may use palbociclib instead. The claim has raised wider questions over cancer drug access, patent safeguards and whether the medicines are clinically interchangeable.
The government’s position has come under scrutiny in a case that raises wider questions about access to life-saving patented medicines, the use of public health safeguards under India’s patent law, and the affordability of cancer treatment for thousands of patients.
The case centres on ribociclib, a targeted therapy marketed by Novartis in India under the brand name Kryxana, which costs nearly Rs 70,000 a month and works by blocking specific proteins to stop cancer cells from growing and dividing.
The drug is recommended for patients with hormone receptor-positive (HR-positive), HER2-negative breast cancer – the most common subtype of the disease, accounting for nearly 70–80% of breast cancer cases in India.
Every year, over 2 lakh new breast cancer cases are diagnosed in the country – the highest number among all malignancies.
While the Centre argued in an affidavit that patients could use palbociclib as an alternative, oncologists say the medicines, though belonging to the same class, have distinct clinical indications, evidence and outcomes.
Palbociclib went off patent in India in 2023, leading to its generic versions hitting the market, following which its price came down from around Rs 80,000 a month to just about Rs 3,800-10,000 per month.
Taking note of the issue, the Kerala High Court has asked three government-run cancer institutions to examine whether palbociclib can scientifically substitute ribociclib and submit their views.
The Court is expected to pass its final verdict in the public interest case soon.
PETITION’S ORIGINS
The litigation began with a petition filed by Saroja Radhakrishnan, who was diagnosed with Luminal A breast cancer, an aggressive subtype of HR-positive, HER2-negative disease, in July 2021.
She sought judicial intervention to reduce the cost of ribociclib by directing the government to invoke compulsory licensing provisions under the Patents Act, allowing generic manufacturers to produce affordable versions of the drug.
Radhakrishnan died in 2022, but the Kerala High Court has continued hearing the matter because of its wider public health implications.
The pharmaceutical companies have been issued notices earlier following which they responded before the court. During the hearings, the Union health ministry repeatedly submitted that patients unable to afford ribociclib could instead use palbociclib, another drug from the same class of Cyclin-Dependent Kinase (CDK) 4/6 inhibitors.
That submission has now become one of the central issues before the court.
SUBSTITUTION QUESTION
The Kerala High Court recently directed three leading government-run cancer institutions – Chittaranjan National Cancer Institute, Kolkata; the National Cancer Institute, Jhajjar; and the Regional Cancer Centre, Thiruvananthapuram – to examine the scientific and clinical issues surrounding the proposed substitution and submit reports within three weeks.
The Drug Controller General of India (DGCI) has also been impleaded in the proceedings.
The matter has also drawn the attention of the Supreme Court. On July 17, the apex court took suo motu cognisance of the broader issue of access to life-saving medicines, issued a notice on the public interest matter and directed the Kerala High Court to expedite the pending writ petition.
The intervention followed representations from the Working Group on Access to Medicines and Treatment, which argued that the case highlights the government's failure to use public health safeguards available under the Patents Act, including compulsory licencing or government-use licences, to improve access to essential medicines.
The group has also objected to the Centre’s argument that ribociclib can simply be replaced with palbociclib. In letters to the Chief Justice of India, president and the Karala High Court, pointed out that while both drugs belong to the CDK4/6 inhibitor class, international regulators have approved them for different clinical settings.
According to the group, both the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have approved ribociclib and abemaciclib for early-stage HR-positive, HER2-negative breast cancer, whereas palbociclib is approved only for metastatic disease, making the medicines unsuitable as direct substitutes.
DOCTORS WEIGH IN
Medical oncologists say the three CDK4/6 inhibitors – ribociclib, palbociclib and abemaciclib – target the same biological pathway but differ in their evidence, approved indications and side-effect profiles.
"They are not interchangeable," said Dr Abhishek Yadav, director, medical oncology, Yashoda Medicity, noting that ribociclib has demonstrated an overall survival benefit in clinical trials, whereas palbociclib, despite improving progression-free survival, did not show the same survival advantage.
Ribociclib has transformed the treatment of HR-positive, HER2-negative breast cancer since its approval for metastatic disease in 2017 and is now also approved for early-stage, high-risk breast cancer after surgery. Used alongside hormonal therapies such as letrozole or fulvestrant, it has significantly improved outcomes for patients with advanced disease.
Dr Yadav said Indian data have also reinforced the drug's effectiveness. A study conducted in Army hospitals involving patients with metastatic HR-positive breast cancer found ribociclib produced a median progression-free survival of nearly 43 months, compared with 39 months for palbociclib, although the difference was not statistically significant.
Dr Indoo Ambulkar, Senior Medical Oncologist at HCG Cancer Hospitals, Mumbai, said ribociclib is used in both early-stage, high-risk breast cancer and advanced or metastatic disease, usually in combination with aromatase inhibitors or fulvestrant depending on the stage of illness.
While other CDK4/6 inhibitors are available, their use depends on the clinical setting, with abemaciclib also approved for early-stage disease but palbociclib primarily used in metastatic cancer.
The government’s position has come under scrutiny in a case that raises wider questions about access to life-saving patented medicines, the use of public health safeguards under India’s patent law, and the affordability of cancer treatment for thousands of patients.
The case centres on ribociclib, a targeted therapy marketed by Novartis in India under the brand name Kryxana, which costs nearly Rs 70,000 a month and works by blocking specific proteins to stop cancer cells from growing and dividing.
The drug is recommended for patients with hormone receptor-positive (HR-positive), HER2-negative breast cancer – the most common subtype of the disease, accounting for nearly 70–80% of breast cancer cases in India.
Every year, over 2 lakh new breast cancer cases are diagnosed in the country – the highest number among all malignancies.
While the Centre argued in an affidavit that patients could use palbociclib as an alternative, oncologists say the medicines, though belonging to the same class, have distinct clinical indications, evidence and outcomes.
Palbociclib went off patent in India in 2023, leading to its generic versions hitting the market, following which its price came down from around Rs 80,000 a month to just about Rs 3,800-10,000 per month.
Taking note of the issue, the Kerala High Court has asked three government-run cancer institutions to examine whether palbociclib can scientifically substitute ribociclib and submit their views.
The Court is expected to pass its final verdict in the public interest case soon.
PETITION’S ORIGINS
The litigation began with a petition filed by Saroja Radhakrishnan, who was diagnosed with Luminal A breast cancer, an aggressive subtype of HR-positive, HER2-negative disease, in July 2021.
She sought judicial intervention to reduce the cost of ribociclib by directing the government to invoke compulsory licensing provisions under the Patents Act, allowing generic manufacturers to produce affordable versions of the drug.
Radhakrishnan died in 2022, but the Kerala High Court has continued hearing the matter because of its wider public health implications.
The pharmaceutical companies have been issued notices earlier following which they responded before the court. During the hearings, the Union health ministry repeatedly submitted that patients unable to afford ribociclib could instead use palbociclib, another drug from the same class of Cyclin-Dependent Kinase (CDK) 4/6 inhibitors.
That submission has now become one of the central issues before the court.
SUBSTITUTION QUESTION
The Kerala High Court recently directed three leading government-run cancer institutions – Chittaranjan National Cancer Institute, Kolkata; the National Cancer Institute, Jhajjar; and the Regional Cancer Centre, Thiruvananthapuram – to examine the scientific and clinical issues surrounding the proposed substitution and submit reports within three weeks.
The Drug Controller General of India (DGCI) has also been impleaded in the proceedings.
The matter has also drawn the attention of the Supreme Court. On July 17, the apex court took suo motu cognisance of the broader issue of access to life-saving medicines, issued a notice on the public interest matter and directed the Kerala High Court to expedite the pending writ petition.
The intervention followed representations from the Working Group on Access to Medicines and Treatment, which argued that the case highlights the government's failure to use public health safeguards available under the Patents Act, including compulsory licencing or government-use licences, to improve access to essential medicines.
The group has also objected to the Centre’s argument that ribociclib can simply be replaced with palbociclib. In letters to the Chief Justice of India, president and the Karala High Court, pointed out that while both drugs belong to the CDK4/6 inhibitor class, international regulators have approved them for different clinical settings.
According to the group, both the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have approved ribociclib and abemaciclib for early-stage HR-positive, HER2-negative breast cancer, whereas palbociclib is approved only for metastatic disease, making the medicines unsuitable as direct substitutes.
DOCTORS WEIGH IN
Medical oncologists say the three CDK4/6 inhibitors – ribociclib, palbociclib and abemaciclib – target the same biological pathway but differ in their evidence, approved indications and side-effect profiles.
"They are not interchangeable," said Dr Abhishek Yadav, director, medical oncology, Yashoda Medicity, noting that ribociclib has demonstrated an overall survival benefit in clinical trials, whereas palbociclib, despite improving progression-free survival, did not show the same survival advantage.
Ribociclib has transformed the treatment of HR-positive, HER2-negative breast cancer since its approval for metastatic disease in 2017 and is now also approved for early-stage, high-risk breast cancer after surgery. Used alongside hormonal therapies such as letrozole or fulvestrant, it has significantly improved outcomes for patients with advanced disease.
Dr Yadav said Indian data have also reinforced the drug's effectiveness. A study conducted in Army hospitals involving patients with metastatic HR-positive breast cancer found ribociclib produced a median progression-free survival of nearly 43 months, compared with 39 months for palbociclib, although the difference was not statistically significant.
Dr Indoo Ambulkar, Senior Medical Oncologist at HCG Cancer Hospitals, Mumbai, said ribociclib is used in both early-stage, high-risk breast cancer and advanced or metastatic disease, usually in combination with aromatase inhibitors or fulvestrant depending on the stage of illness.
While other CDK4/6 inhibitors are available, their use depends on the clinical setting, with abemaciclib also approved for early-stage disease but palbociclib primarily used in metastatic cancer.
The government’s position has come under scrutiny in a case that raises wider questions about access to life-saving patented medicines, the use of public health safeguards under India’s patent law, and the affordability of cancer treatment for thousands of patients.
The case centres on ribociclib, a targeted therapy marketed by Novartis in India under the brand name Kryxana, which costs nearly Rs 70,000 a month and works by blocking specific proteins to stop cancer cells from growing and dividing.
The drug is recommended for patients with hormone receptor-positive (HR-positive), HER2-negative breast cancer – the most common subtype of the disease, accounting for nearly 70–80% of breast cancer cases in India.
Every year, over 2 lakh new breast cancer cases are diagnosed in the country – the highest number among all malignancies.
While the Centre argued in an affidavit that patients could use palbociclib as an alternative, oncologists say the medicines, though belonging to the same class, have distinct clinical indications, evidence and outcomes.
Palbociclib went off patent in India in 2023, leading to its generic versions hitting the market, following which its price came down from around Rs 80,000 a month to just about Rs 3,800-10,000 per month.
Taking note of the issue, the Kerala High Court has asked three government-run cancer institutions to examine whether palbociclib can scientifically substitute ribociclib and submit their views.
The Court is expected to pass its final verdict in the public interest case soon.
PETITION’S ORIGINS
The litigation began with a petition filed by Saroja Radhakrishnan, who was diagnosed with Luminal A breast cancer, an aggressive subtype of HR-positive, HER2-negative disease, in July 2021.
She sought judicial intervention to reduce the cost of ribociclib by directing the government to invoke compulsory licensing provisions under the Patents Act, allowing generic manufacturers to produce affordable versions of the drug.
Radhakrishnan died in 2022, but the Kerala High Court has continued hearing the matter because of its wider public health implications.
The pharmaceutical companies have been issued notices earlier following which they responded before the court. During the hearings, the Union health ministry repeatedly submitted that patients unable to afford ribociclib could instead use palbociclib, another drug from the same class of Cyclin-Dependent Kinase (CDK) 4/6 inhibitors.
That submission has now become one of the central issues before the court.
SUBSTITUTION QUESTION
The Kerala High Court recently directed three leading government-run cancer institutions – Chittaranjan National Cancer Institute, Kolkata; the National Cancer Institute, Jhajjar; and the Regional Cancer Centre, Thiruvananthapuram – to examine the scientific and clinical issues surrounding the proposed substitution and submit reports within three weeks.
The Drug Controller General of India (DGCI) has also been impleaded in the proceedings.
The matter has also drawn the attention of the Supreme Court. On July 17, the apex court took suo motu cognisance of the broader issue of access to life-saving medicines, issued a notice on the public interest matter and directed the Kerala High Court to expedite the pending writ petition.
The intervention followed representations from the Working Group on Access to Medicines and Treatment, which argued that the case highlights the government's failure to use public health safeguards available under the Patents Act, including compulsory licencing or government-use licences, to improve access to essential medicines.
The group has also objected to the Centre’s argument that ribociclib can simply be replaced with palbociclib. In letters to the Chief Justice of India, president and the Karala High Court, pointed out that while both drugs belong to the CDK4/6 inhibitor class, international regulators have approved them for different clinical settings.
According to the group, both the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have approved ribociclib and abemaciclib for early-stage HR-positive, HER2-negative breast cancer, whereas palbociclib is approved only for metastatic disease, making the medicines unsuitable as direct substitutes.
DOCTORS WEIGH IN
Medical oncologists say the three CDK4/6 inhibitors – ribociclib, palbociclib and abemaciclib – target the same biological pathway but differ in their evidence, approved indications and side-effect profiles.
"They are not interchangeable," said Dr Abhishek Yadav, director, medical oncology, Yashoda Medicity, noting that ribociclib has demonstrated an overall survival benefit in clinical trials, whereas palbociclib, despite improving progression-free survival, did not show the same survival advantage.
Ribociclib has transformed the treatment of HR-positive, HER2-negative breast cancer since its approval for metastatic disease in 2017 and is now also approved for early-stage, high-risk breast cancer after surgery. Used alongside hormonal therapies such as letrozole or fulvestrant, it has significantly improved outcomes for patients with advanced disease.
Dr Yadav said Indian data have also reinforced the drug's effectiveness. A study conducted in Army hospitals involving patients with metastatic HR-positive breast cancer found ribociclib produced a median progression-free survival of nearly 43 months, compared with 39 months for palbociclib, although the difference was not statistically significant.
Dr Indoo Ambulkar, Senior Medical Oncologist at HCG Cancer Hospitals, Mumbai, said ribociclib is used in both early-stage, high-risk breast cancer and advanced or metastatic disease, usually in combination with aromatase inhibitors or fulvestrant depending on the stage of illness.
While other CDK4/6 inhibitors are available, their use depends on the clinical setting, with abemaciclib also approved for early-stage disease but palbociclib primarily used in metastatic cancer.
