Expert’s opinion to HC contradicts govt stand on patented cancer drug | India News
NEW DELHI: Contradicting the government claim that generic breast cancer drug palbociclib can be used as an alternative to patented drugs in the same group, noted oncologist and Magsaysay award winner Dr R Ravi Kannan has opined that these drugs are not interchangeable. He explained that ribociclib benefits early-stage breast cancer and can reduce recurrence and improve overall survival, while palbociclib trials have shown that it has no role in early breast cancer treatment.Dr Kannan, the director of Cachar Cancer Hospital and Research Centre, Silchar, a nonprofit hospital that provides free cancer treatment, gave his opinion in a case before the Kerala High Court filed by a patient seeking access to expensive patented breast cancer drugs. After the patient’s death, the court took it up suo moto in public interest. It concerned the most common breast cancer subtype, hormone receptor positive and HER2-negative tumors.The petition sought a government use licence under section 100 of the Patent Act, to enable access to ribociclib, a patented drug, at affordable prices. However, government refused to issue a government use licence stating that breast cancer did not constitute a matter of national emergency and that the National Cancer Institute in Jhajjar, and Chittaranjan National Cancer Institute in Kolkata had said that generic palbociclib could be used as an alternative to ribociclib.Dr Kannan’s letter stated that despite palbociclib, abemaciclib and ribociclib being CDK4/6 inhibitors, they “cannot be interchanged in the early breast cancer (adjuvant) setting”. He cited the trial which showed that adding abemaciclib to endocrine therapy significantly reduced recurrence, and extended follow up of seven years showed significant invasive disease-free survival and improved overall survival. He also cited trials that found that giving ribociclib for three years along with non-steroidal aromatase inhibitor, a type of hormone therapy drug used to treat hormone receptor-positive breast cancer, significantly improved the outcomes. The trial showed significant improvement in invasive disease-free survival and reduction in recurrence of the cancer in parts of the body far from the original breast tumor. He added that two large trials had shown that palbociclib in early breast cancer did not show similar advantages.Citing the trial results, Dr Kannan stated that the approval of generic palbociclib in India should not be seen as providing an equivalent adjuvant option. “Clinicians must use the evidence-based drugs–abemaciclib or ribociclib–when indicated for high risk early-stage patients, since palbociclib’s adjuvant trials showed no benefit,” stated the letter.He pointed out that the high cost of abemaciclib and ribociclib meant that vast numbers of high-risk patients who could benefit from these drugs simply could not obtain them. Ribociclib is over Rs 78,400 per month and Abemaciclib Rs 47,700 to 95,500 per month.“Generic entry has historically been the single most reliable lever for expanding access to targeted cancer therapies in resource-limited settings, and there is no clinical reason to expect abemaciclib and ribociclib to be an exception,” stated Dr Kannan adding that only by substantially lowering prices can the lifesaving benefits of these drugs reach the broad population of high-risk patients in India.The latest affidavit submitted on August 14 by the Central Drugs Standard Control Organisation (CDSCO), the apex regulator for pharmaceuticals in India, includes tables that show that both palbociclib and ribociclib are approved for HR-positive, HER2-negative advanced or metastatic breast cancer. But the affidavit also records a separate January 2026 approval for ribociclib for early-stage breast cancer in patients at high risk of recurrence. “CDSCO’s own data shows an additional early-stage breast cancer indication for ribociclib that is not shown for palbociclib. Yet the affidavit then says the two medicines have been approved for the same indications. This is a serious contradiction. A drug regulator has a responsibility to place clear and accurate information before the court, particularly when women’s access to life-saving treatment is at stake,” said Gargeya Telakapalli, co-ordinator, Working Group on Access to Medicines and Treatments.
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“Nearly one lakh women are dying of breast cancer every year. If that is not a public health emergency, what is? This case has been going on since 2022. The woman who first approached the Court died before she could get the medicine she needed. Many more women have died while this case has continued. The government cannot keep treating access to breast cancer medicines as an ordinary pricing dispute. Women need the best available treatment when it can still save their lives,” said Jyotsna Singh, co-convener of the Working Group.
