Recommendations of the SEC (Oncology &Haematology) made in its 92nd meeting held on 03.12.2019 at CDSCO HQ New Delhi: Agenda File Name & Firm Name Recommendations No Drug Name, Strength New Drugs Division 12-01/19-DC (Pt- M/s. Tata In light of recommendations of SEC 1 128) Memorial meeting held on 13.08.2019, the Cannabinoids Centre applicant presented the proposal along with the protocol for conducting clinical trial with the product Cannabinoids (Bedrocan – cannabis flos). After detailed deliberation, the committee recommended for grant of permission to conduct clinical trial subject to submission and evaluation by CDSCO as per rule of the following: 1. Detailed flow sheet from cultivation, collection & processing, manufacturing etc of the product. 2. The complete composition of the sachet along with the specification with upper & lower limit of phyto- constituents. Dr S D Banavali did not take part in the deliberation. Biological Division In light of recommendations of SEC 2 meeting held on 13.08.2019, the firm presented the results of clinical trial 4-37/Roche/PAC- from other countries for approval of R-Trastuzumab M/s. Roche additional indication along with Emtansine/19-BD Products (India) interim Phase IV clinical study data Trastuzumab Pvt. Ltd. of the drug in approved indication. Emtansine After detailed deliberation, the committee recommended for grant of permission to market the drug for proposed additional indication. 01/Phase The firm didn’t turn up for the 3 IV/Biocad/19-BD M/s. Biocad presentation. Trastuzumab BIO/Form44/FF/ M/s Reliance 4 2019/15306 The firm didn’t turn up for the Life Sciences Ramucirumab presentation. Pvt Ltd Injection 91thSEC (Oncology & Haematology) _06.11.2019 Agenda File Name & Firm Name Recommendations No Drug Name, Strength In light of recommendation of the 5 SEC meeting held on 26.09.2019, the firm intended to make presentation for Phase III clinical trial protocol BIO/Form44/FF/20 before the committee instead of re- 19/15560 deliberation for Phase III waiver. M/s Eris Recombinant The committee however noted that Lifesciences Human the Phase III clinical trial proposal Limited Thrombopoietin has not been submitted to CDSCO. Therefore, the committee recommended that the firm should first submit the Phase III clinical trial proposal along with the protocol for further consideration. The firm presented their results of 6 Phase IV clinical trial. After detailed 56/Phase deliberation, the committee IV/Roche/14-BD M/s Roche recommended that the firm should (Part-I) Product present the above data along with Pertuzumab comparison with the global data and also PSUR data. BIO/CT/19/000078 M/s. Sun The firm didn’t turn up for the 7 Bevacizumab Pharmaceuticals presentation. The firm presented their proposal 8 along with Phase II clinical trial data for import and marketing of the drug for Merkel cell carcinoma. The committee noted that Merkel cell carcinoma is a rare disease in India M/s Merck BIO/IMP/19/00005 and presently there is no alternative Specialities 1 therapy available. The drug is already Private Limited Avelumab approved in USA, Europe, Australia, etc. After detailed deliberation the committee recommended for grant of permission to import and market the drug for the proposed indication with Phase III clinical trial wavier. 9 In light of the recommendation of the SEC in its meeting held on 28.04.2017, the firm stated that it has 4-54/J&J/PAC-R- initiated the Phase IV study and also Daratumumab/17- M/s Johnson & presented its proposal for approval of BD Johnson additional indication. Daratumumab Committee noted that the proposed additional indication was approved in USA, EU etc. Proposed indication is a rare condition and there is an unmet 91thSEC (Oncology & Haematology) _06.11.2019 Agenda File Name & Firm Name Recommendations No Drug Name, Strength need. After detailed deliberation, committee recommended for grant of approval of the proposed additional indication. GCT Division 10 CT/85/19 M/s. Lambda The firm presented their proposal for Goserelin Therapeutic Phase III clinical trial. After detailed deliberation the committee recommended for grant of permission to conduct the clinical trial. CT/84/19 M/s. Lambda The firm presented their proposal for 11 Goserelin Therapeutic Phase III clinical trial. After detailed deliberation the committee recommended for grant of permission to conduct the clinical trial. CT/89/19 M/s. Novartis Applicant presented their proposal 12 Capmatinib along with study protocol before the committee. Assessment of risk versus benefit to the patients- The safety profile of the study drug from various preclinical toxicology studies and clinical studies justify the conduct of the trial. Innovation vis-a-vis existing therapeutic- To evaluating the efficacy and safety of capmatinib (INC280) plus pembrolizumab versus pembrolizumab alone as first line treatment for locally advanced or metastatic non-small cell lung cancer with PD-L1≥50%. Unmet medical need in the country- To develop safe and efficacious treatment for locally advanced or metastatic non-small cell lung cancer. After detailed deliberation the committee recommended for grant of permission to conduct the study. 91thSEC (Oncology & Haematology) _06.11.2019 CT/88/19 M/s. Pfizer Applicant presented their proposal 13 PF-06741086 along with study protocol before the committee. Assessment of risk vs. Benefit to the patients: The safety profile of the study drugs from preclinical toxicology studies including Single- Dose Toxicity, repeat dose toxicity, Phase I & II clinical study justify the conduct of the trial. Innovation vis-à-vis Existing Therapeutic option: The Purpose of the study is to demonstrate the efficacy and safety of PF-06741086 for routine prophylaxis in severe (FVIII or FIX activity<1%) hemophilia A or B patients 12 to <75 years of age with or without inhibitors. Unmet Medical need in the country: The test drug may potentially provide treatment in Adolescent and Adult Severe (Coagulation Factor Activity <1%) Hemophilia A or B Patients with or without Inhibitors Comparing Standard Treatment to PF-06741086 Prophylaxis. After detailed deliberation the committee recommended for grant of permission to conduct the study. 91thSEC (Oncology & Haematology) _06.11.2019 .