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Patent rulings raise hope for cheap cancer drugs in India
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Patient groups in India hope cancer treatment will become affordable to the poorest citizens in the near future after a series of recent rulings by patent authorities and courts on key cancer drugs. The cancer drugs affected by the patent rulings include variants of sorafenib (marketed by Bayer as Nexavar), imatinib (marketed by Novartis as Glivec [or Gleevec in the USA]), and lapatinib (marketed by GSK as Tykerb). The latest ruling was the dismissal of Roche’s applications for additional patents on a secondary patent it holds in India for the breast cancer drug, trastuzumab (Herceptin). Following this decision, Roche has decided not to pursue the secondary patent itself even though it could have remained effective until 2019. The company’s statement attributed the move to the intellectual property environment in India.
“Roche backed out because it knew that its patent was weak and wobbly. Herceptin was not patentable under Indian law since it was developed prior to 1995. The patent Roche has relinquished now was for a combination of HER2-positive antibody with acidic variants, which we challenged because it violates section 3(d) of patent law under which derivatives of known substances can’t be patented”, pointed out Kalyani Menon-Sen (Campaign for Affordable Trastuzumab, Gurgaon, India). Availability of cheap generic versions of existing drugs is expected to improve cancer treatment in India. “At present we have over 100 000 HER2-positive breast cancer cases and just 5% of them can afford treatment with Herceptin”, said Yogendra Kumar Sapru (Cancer Patients Aid Association, Mumbai, India).
However, bringing in cheap versions of cancer drugs might still face hurdles. Generic versions of biological molecules—known as biosimilars—are required to be similar in terms of safety, efficacy, and quality to original molecules already approved, based on full data and safety history. “Indian regulatory guidelines prepared in consultation with industry may actually act as barriers to the introduction of biosimilars”, said Menon-Sen. “In the absence of a well-defined regulatory pathway to assess quality of more affordable biologic drugs, developing countries are setting higher standards for biosimilars which, in turn, poses barriers to access”, cautions Leena Menghaney (Médecins Sans Frontières, Delhi, India).
Volker Steger/Science Photo Library
Patent rulings raise hope for cheap cancer drugs in India
Published Online August 23, 2013 http://dx.doi.org/10.1016/ S1470-2045(13)70395-4
Dinesh C Sharma
Pixantrone or doxorubicin for diffuse large B-cell lymphoma? The CPOP-R regimen—which replaces doxorubicin with pixantrone in the established first-line regimen for diffuse large B-cell lymphoma—could be a useful new treatment option. Compared with CHOP-R (cyclophosphamide, doxorubicin, vincristine, and prednisone with rituximab), the CPOP-R regimen was associated with modestly reduced overall survival but similar progression-free survival, event-free survival, and a reduced incidence of severe cardiac side-effects according to a new study. Researchers compared the efficacy and safety of CHOP-R with CPOP-R as first-line therapy in patients with diffuse large B-cell lymphoma. 46 (75%) of 61 patients in the CPOP-R group had a confirmed or unconfirmed complete response compared with 53 (84%) of 63 for CHOP-R, a finding that did not meet the non-inferiority criteria set as www.thelancet.com/oncology Vol 14 October 2013
the primary outcome. 3 year overall survival was lower with CPOP-R than with CHOP-R (69% vs 85%; p=0·029), as was the overall response rate (82% vs 90%). However, more patients in the CHOP-R group had declines in left ventricular ejection fraction, severe congestive heart failure, and greater troponin shift to a higher grade toxic effect. Notably, doxorubicinbased chemotherapy increased the risk of serious cardiac side-effects in up to 30% of patients with diffuse large B-cell lymphoma. Pixantrone binds topoisomerase and does not produce cardiotoxic metabolites as doxorubicin does. Corrado Tarella (University of Torino, Torino, Italy) noted, “It is not clear why there were significant survival discrepancies though there were analogous PFS curves for the two treatment arms: additional information might be useful to clarify
these apparent discrepancies”. He added: “Nevertheless, the finding that an effective new drug, pixantrone, is now available for aggressive B-cell lymphoma is definitely important”. Bertrand Coiffier (Hospices Civils de Lyons, Lyon, France) thinks that current study will not change standard first line management. He further notes “However, combined with the paper in The Lancet Oncology on pixantrone alone, it shows that this drug has activity and less cardiac toxicity than in patients treated with doxorubicin. So, pixantrone will certainly be interesting to incorporate in a salvage regimen for first relapse.” Both commentators agree that further studies confirming these results in first-line or other settings are needed before firm conclusions about pixantrone-based therapy can be made.
Published Online August 23, 2013 http://dx.doi.org/10.1016/ S1470-2045(13)70396-6 For the study see Ann Oncol 2013; published online Aug 14. DOI:10.1093/annonc/mdt289 For the study on pixantrone alone see Articles Lancet Oncol 2012; 13: 696–706
Sharan Prakash Sharma e441
Patient groups in India hope cancer treatment will become affordable to the poorest citizens in the near future after a series of recent rulings by patent authorities and courts on key cancer drugs. The cancer drugs affected by the patent rulings include variants of sorafenib (marketed by Bayer as Nexavar), imatinib (marketed by Novartis as Glivec [or Gleevec in the USA]), and lapatinib (marketed by GSK as Tykerb). The latest ruling was the dismissal of Roche’s applications for additional patents on a secondary patent it holds in India for the breast cancer drug, trastuzumab (Herceptin). Following this decision, Roche has decided not to pursue the secondary patent itself even though it could have remained effective until 2019. The company’s statement attributed the move to the intellectual property environment in India.
“Roche backed out because it knew that its patent was weak and wobbly. Herceptin was not patentable under Indian law since it was developed prior to 1995. The patent Roche has relinquished now was for a combination of HER2-positive antibody with acidic variants, which we challenged because it violates section 3(d) of patent law under which derivatives of known substances can’t be patented”, pointed out Kalyani Menon-Sen (Campaign for Affordable Trastuzumab, Gurgaon, India). Availability of cheap generic versions of existing drugs is expected to improve cancer treatment in India. “At present we have over 100 000 HER2-positive breast cancer cases and just 5% of them can afford treatment with Herceptin”, said Yogendra Kumar Sapru (Cancer Patients Aid Association, Mumbai, India).
However, bringing in cheap versions of cancer drugs might still face hurdles. Generic versions of biological molecules—known as biosimilars—are required to be similar in terms of safety, efficacy, and quality to original molecules already approved, based on full data and safety history. “Indian regulatory guidelines prepared in consultation with industry may actually act as barriers to the introduction of biosimilars”, said Menon-Sen. “In the absence of a well-defined regulatory pathway to assess quality of more affordable biologic drugs, developing countries are setting higher standards for biosimilars which, in turn, poses barriers to access”, cautions Leena Menghaney (Médecins Sans Frontières, Delhi, India).
Volker Steger/Science Photo Library
Patent rulings raise hope for cheap cancer drugs in India
Published Online August 23, 2013 http://dx.doi.org/10.1016/ S1470-2045(13)70395-4
Dinesh C Sharma
Pixantrone or doxorubicin for diffuse large B-cell lymphoma? The CPOP-R regimen—which replaces doxorubicin with pixantrone in the established first-line regimen for diffuse large B-cell lymphoma—could be a useful new treatment option. Compared with CHOP-R (cyclophosphamide, doxorubicin, vincristine, and prednisone with rituximab), the CPOP-R regimen was associated with modestly reduced overall survival but similar progression-free survival, event-free survival, and a reduced incidence of severe cardiac side-effects according to a new study. Researchers compared the efficacy and safety of CHOP-R with CPOP-R as first-line therapy in patients with diffuse large B-cell lymphoma. 46 (75%) of 61 patients in the CPOP-R group had a confirmed or unconfirmed complete response compared with 53 (84%) of 63 for CHOP-R, a finding that did not meet the non-inferiority criteria set as www.thelancet.com/oncology Vol 14 October 2013
the primary outcome. 3 year overall survival was lower with CPOP-R than with CHOP-R (69% vs 85%; p=0·029), as was the overall response rate (82% vs 90%). However, more patients in the CHOP-R group had declines in left ventricular ejection fraction, severe congestive heart failure, and greater troponin shift to a higher grade toxic effect. Notably, doxorubicinbased chemotherapy increased the risk of serious cardiac side-effects in up to 30% of patients with diffuse large B-cell lymphoma. Pixantrone binds topoisomerase and does not produce cardiotoxic metabolites as doxorubicin does. Corrado Tarella (University of Torino, Torino, Italy) noted, “It is not clear why there were significant survival discrepancies though there were analogous PFS curves for the two treatment arms: additional information might be useful to clarify
these apparent discrepancies”. He added: “Nevertheless, the finding that an effective new drug, pixantrone, is now available for aggressive B-cell lymphoma is definitely important”. Bertrand Coiffier (Hospices Civils de Lyons, Lyon, France) thinks that current study will not change standard first line management. He further notes “However, combined with the paper in The Lancet Oncology on pixantrone alone, it shows that this drug has activity and less cardiac toxicity than in patients treated with doxorubicin. So, pixantrone will certainly be interesting to incorporate in a salvage regimen for first relapse.” Both commentators agree that further studies confirming these results in first-line or other settings are needed before firm conclusions about pixantrone-based therapy can be made.
Published Online August 23, 2013 http://dx.doi.org/10.1016/ S1470-2045(13)70396-6 For the study see Ann Oncol 2013; published online Aug 14. DOI:10.1093/annonc/mdt289 For the study on pixantrone alone see Articles Lancet Oncol 2012; 13: 696–706
Sharan Prakash Sharma e441