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Recommendations of the 99Th SEC (Oncology & Haematology)

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Recommendations of the 99Th SEC (Oncology & Haematology) Recommendations of the 99th SEC (Oncology & Haematology) Meeting held on 21.07.2020 & 22.07.2020 at CDSCO, HQ New Delhi: Agenda File Name & Drug Firm Name Recommendations No Name, Strength New Drug Division The firm Presented their proposal along with the protocol for Phase IV study. After detailed deliberation, the committee recommended for grant of permission to conduct the proposed Phase IV study with the F. No. ND/MA/19/00009 following changes: M/s MSN Pvt. 1. Bosutinib Tablets 100 Ltd. 1. At least 50% of patients to be enrolled mg, 400 mg, 500 mg should be Imatinib resistant CML. 2. The drug should be provided free of cost to responders till progression even after completion of planned study as part of post trial access as per rules. 3. PI should be medical oncologist or Haematologist. Dr. Anusuya F. No 12-01/19-DC (Pt- Gehlot, Member Secretary, 322) The committee opined that the proposal needs 2. Institutional to be deliberated in SEC (Neurology) along Platelet Rich Plasma Ethics with experts from Blood Bank & ENT. (PRP) Committee, Dr. SNMC, Jodhpur In light of recommendation of SEC dated 29.05.2020, the firm presented the protocol for ND/MA/19/000010 M/s BDR multiple dose, steady state BE study. 3. Pharmaceuticals Rucaparib tablets Limited After detailed deliberation, the committee recommended for grant of permission to conduct the BE study as per protocol presented. SND Division The firm presented their proposal for additional indication along with request for local clinical trial waiver. The committee opined that there is an unmet SND/IMP/20/000015 medical need for this disease condition which is serious and life threatening. 4. Olaparib Film coated M/s AstraZeneca The proposed additional indication is already tablets 100/150 mg approved in US under priority review. After detailed deliberation the committee recommended for grant of permission to market Olaparib Film coated tablets 100/150 mg for the proposed additional indication. 99th SEC (Oncology & Haematology) Meeting held on 21.07.2020 & 22.07.2020 Agenda File Name & Drug Firm Name Recommendations No Name, Strength The firm presented their proposal for additional indication along with request for local clinical trial waiver. The committee opined that there is an unmet SND/IMP/20/000020 medical need for this disease condition which is serious and life threatening. 5. Olaparib Film coated M/s AstraZeneca The proposed additional indication is already tablets 100/150 mg approved in US under priority review. After detailed deliberation the committee recommended for grant of permission to market Olaparib Film coated tablets 100/150 mg for the proposed additional indication. The firm presented their proposal for additional indication along with request for local clinical trial waiver. The committee opined that there is an unmet medical need for the serious life threatening SND/IMP/20/000060 disease- Hepatocellular carcinomas (HCC) who have been previously treated with 6. Regorafenib 40mg film M/s Bayer sorafenib. coated tablets The proposed additional indication is already approved in US, EU, Japan, Canada, Australia, Taiwan etc. After detailed deliberation the committee recommended for grant of permission to market Regorafenib 40mg film coated tablets for the proposed additional indication. The firm presented their proposal for conducting Phase–I Clinical trial for Liposomal Docetaxel Injection 20mg/vial. After detailed deliberation the committee SND/CT/20/000023 recommended for grant of permission for M/s Shilpa conduct of Phase I Clinical Trial subject to 7. Liposomal Docetaxel Medicare condition that the firm should also generate Injection 20mg/vial the PK data in the same study and accordingly the firm should submit the protocol amendment incorporating details about assessment of the PK profile of the drug. In light of recommendation of 87th SEC dated 13.08.2019, firm presented BE Study report for Enzalutamide Hard Gelatine capsules 80 SND/MA/19/000081 mg. M/s BDR After detailed deliberation the committee 8. Enzalutamide Hard recommended for grant of permission for Gelatine Capsule 80 mg manufacturing and marketing of Enzalutamide Hard Gelatine capsules 80 mg as an additional strength. 99th SEC (Oncology & Haematology) Meeting held on 21.07.2020 & 22.07.2020 Agenda File Name & Drug Firm Name Recommendations No Name, Strength GCT Division The firm presented their proposal for grant of permission to conduct Phase 3 global clinical trial. Assessment of risk vs. Benefit to the patients: The safety profile of the study drug from preclinical and clinical studies justify the conduct of the trial. Innovation vis-à-vis Existing Therapeutic option: CT/50/20 To compare the effect of capivasertib + abiraterone relative to placebo + abiraterone by assessment of Online Submission radiographic progression-free survival (rPFS) in 9. (19950) Dated 29/05/20 M/s AstraZeneca patients with PTEN-deficient mHSPC. Capivasertib+Abirateron Unment Medical Need In The Country: The e current investigating drugs as Treatment for Patients with De Novo Metastatic Hormone-Sensitive Prostate Cancer (mHSPC) Characterized by PTEN deficiency (CAPItello-281) an unmet medical need. After detailed deliberation the committee recommended for grant of permission to conduct the study. The firm presented their proposal for grant of permission to conduct phase-3 global clinical trial. Assessment of Risk vs. Benefit to the patients: The safety profile of the study drug from preclinical and clinical studies justify the conduct of the trial. Innovation vis-à-vis Existing Therapeutic CT/54/20 Option: To assess the efficacy of Trastuzumab Deruxtecan(T-DXd) compared Online Submission with investigator’s choice chemotherapy in M/s AstraZeneca 10. (20191) Dated 16/06/20 terms of PFS by BICR in theHR+,HER2-low (IHC2+/ISH-and IHC 1+) population. Trastuzumab Deruxtecan Unmet Medical Need in the country: The test drug may potentially provide alternate treatment option inHER2-low, Hormone Receptor Positive Breast Cancer Patients whose Disease has Progressed on Endocrine Therapy in the Metastatic Setting. After detailed deliberation the committee recommended for grant of permission to conduct the study. 99th SEC (Oncology & Haematology) Meeting held on 21.07.2020 & 22.07.2020 Agenda File Name & Drug Firm Name Recommendations No Name, Strength Biological Division BIO/CT04/FF/2020/1874 In light of recommendation of SEC dated 0 09.04.2019, the firm presented the Phase IV M/s Baxalta protocol before the committee. Coagulation Factor VIII 11. Bioscience India (Recombinant) rFVIII, Pvt.Ltd The Committee after detailed deliberation, Plasma/Albumin Free recommended for grant of permission to Method; Octocog Alfa conduct the Phase IV study as per protocol presented. The firm presented their proposal for amendment in already approved clinical trial 4-441/Cadila protocol. Healthcare/17-BD M/s Cadila The Committee after detailed deliberation, 12. Healthcare Ltd. recommended for grant of approval for Trastuzumab proposed amendments to the protocol presented. BIO/CT04/FF/2020/1957 0 (CDSCO File No.: The firm presented their proposal for conduct BIO/CT/20/000058) M/s Bristol- of Phase IV clinical trial. The Committee after detailed deliberation, 13. Myers Squibb Ipilimumab (YERVOI) 5 India Pvt. Ltd. recommended for grant of permission to mg/mL concentrate for conduct the Phase IV clinical trial as per solution for infusion protocol presented. The firm presented their proposal for grant of BIO/CT18/FF/2020/1938 marketing authorization of Rurioctocog alfa 4 (CDSCO File No. : pegol (PEGylated recombinant human FVIII) BIO/IMP/20/000039) along with request for local clinical trial M/s Baxalta waiver. Rurioctocog alfa pegol – The committee noted that 11 Indian patients 14. Bioscience India PEGylated recombinant Pvt.ltd participated in various clinical trial of the human FVIII 250 IU, 500 drug and also the drug is indicated for very rare condition. IU, 750 IU, 1000 IU, 1500 IU and 2000 IU After detailed deliberation the committee recommended for grant of approval for import and marketing the drug in the country. The firm presented their proposal for grant of marketing authorization of Nonacog beta pegol along with request for local clinical trial waiver. BIO/CT18/FF/2020/1920 M/s Novo The committee noted that the drug is 4 indicated for very rare condition and the 15. Nordisk India Pvt. number of patients in the country is very Nonacog beta pegol Ltd small. After detailed deliberation the committee recommended for grant of approval for import and marketing the drug in the country. 99th SEC (Oncology & Haematology) Meeting held on 21.07.2020 & 22.07.2020 Agenda File Name & Drug Firm Name Recommendations No Name, Strength Medical Device Division The firm presented their proposal before the IMP/MD/2020/23432 committee about the tissue marker. The firm presented the clinical data and that the Ultraclip Dual Trigger M/s Bard India product is approved in USA, Europe for more 16. Breast Tissue Healthcare Pvt.ltd than 15 years. After detailed deliberation the committee recommended for grant of import Marker permission for these products with the conditions that the firm shall submit PMS Data after every year. The firm presented their proposal before the committee about the tissue marker. The firm IMP/MD/2020/23451 presented the clinical data and that the product is approved in USA, Europe for more than 15 Gel Mark UltraCor M/s Bard India years. After detailed deliberation the 17. Breast Tissue Healthcare Pvt.ltd committee recommended for grant of import Marker permission for these products with the conditions that the firm shall submit PMS Data after every year. The firm presented their proposal before the committee about the tissue marker. The firm IMP/MD/2020/20352 presented the clinical data and that the product is approved in USA, Europe for more than 15 SenoMark Ultra Breast M/s Bard India years. After detailed deliberation the 18. Tissue Healthcare Pvt.ltd committee recommended for grant of import Marker permission for these products with the conditions that the firm shall submit PMS Data after every year.
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