File no./drug Name Name of firm/ Institute Recommendations. M/s. AstrazenecaPharma India Limited

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1 Recommendations: I agree the minutes of 51 st SEC-Oncology & Haematology meeting held on at CDSCO HQ New Delhi Agenda File /Drug Name Name of firm/ Institute Recommendations New Drugs Division Proposal /16-DC Osimertinib tablets 40 mg/ 80mg M/s. AstrazenecaPharma India Limited The firm has applied for import and marketingof Osimertinib film coated tablets 40 mg & 80 mgwhich is indicated for the treatment of adult patient with locally advanced or metastatic epidermal growth factor receptor (EGFR) T790M mutation-positive nonsmall cell lung cancer (NSCLC). The firm has requested for waiver of local clinical trial. The firm has presented global safety and efficacy data including data from patients of Asian origin. The firm has also stated that the drug was granted orphan status in USA and also approved in 47 countries. After detailed deliberation, the committee opined that there is no effective therapy available for NSCLC patients (EGFR T790M Mutation) who have developed resistance to TKIs. Therefore, the committeerecommended for grant of import and marketing of the drug with local clinical trial

2 File /Drug Name Name of firm/ Institute Recommendations /13-DC Treosulphan Injection 5g/ml Subsequent New Drugs Division Proposal M/s. Emcure Pharmaceuticals Limited waiver for the indication for the treatment of patients with metastatic epidermal growth factor receptor (EGFR) T790M mutation-positive nonsmall cell lung cancer (NSCLC), as detected by an appropriate test, who have progressed on or after EGFR TKI therapy subject to the condition that the firm shall conduct a phase IV clinical trial, the protocol for which should be submitted to the office of the DCGI within 6 months from the date of approval for marketing in the country. The firm presented the pharmacokinetic study report generated on 12 patients in the country. After detailed deliberations, the committee recommended that the firm should submit comparative pk data vis a vis published literature along with appropriate statistical analysis for further consideration /2017-DC Pt(Eisaisnd) Lenvatinib hard gelatin capsule 4mg/10mg (additional Indication) M/s Eisai Pharmaceuticals Pvt ltd Firm presented the proposal for grant of import and marketing of the drug for an additional indication with a local CT wavier. The committee observed that the firm has not launched the drug approved for Thyroid cancer with the local

3 File /Drug Name Name of firm/ Institute Recommendations clinical trial wavier. Further firm has also not submitted Phase IV CT protocol for already approved indication. After detailed deliberation the committee recommended that the firm should submit Phase IV CT data for already approved indication before considering approval for an additional indication with local clinical trial wavier. Global Clinical Trial Division Proposals 4 CT/56/16 SAIT101(Rituximab) M/s. Quintiles Research India Pvt. Ltd Assessment of Risk vs. Benefit to the patients:the safety profile of the study drug from preclinical toxicology studies and clinical studies justify the conduct of the trial. Innovation vis-à-vis Existing Therapeutic Option: First line rituximab monotherapy may delay chemotherapy treatment in patients with LTBFL. Unmet Medical Need in the country:there is unmet medical need for treatment options including biosimilar of rituximab for the growing FL/LTBFL population. After detailed deliberation the committee recommended the conduct of the study. 5 CT/53/16 Eltrombopag M/s. Novartis Assessment of Risk vs. Benefit to the patients: The safety profile of the study drug from preclinical

4 File /Drug Name Name of firm/ Institute Recommendations toxicology studies including Single dose toxicity, repeat dose toxicity, reproductive and developmental toxicity, genotoxicity, Dermal toxicity tests, local tolerance and clinical studies justify the conduct of the trial. Innovation vis-à-vis Existing Therapeutic Option:Eltrombopag may be effective in IST refractory patients. Unmet Medical Need in the country: The current standard of care is Stem cell transplant. The proposed trial is to include Eltrombopag in combination with CsA as first line therapy in Severe Aplastic Anaemia. After detailed deliberation the committee recommended the conduct of the study only in the patients in whom HLA matching has been done and either do not have a HLA match or are not medically fit for Transplant. Same should be clarified in the Inclusion/ Exclusion criteria as SOC for curative intent is Stem cell transplant. Medical Devices Division Proposal MD/2014-DC Application for grant of permission to import and market product i.e., Sterile Solution for Red Blood Cell Glycerolization and Freezing (Glycerol 57% Sterile Solution) under Rule 122A of Drugs & Cosmetics Act & Rules. M/s. Span Healthcare Pvt. Ltd. Bangalore The firm has presented the case before the committee. After deliberation, the committee recommended for grant of approval of marketing authorization of the proposed product.

5 File /Drug Name Name of firm/ Institute Recommendations 7 4-MD/CT-174/2016-DC Application for grant of permission to import and market new medical device i.e., Sterile deglycerolisation solution for de- glycerolisation of preserved human blood cells and sterile washing Solution for washing of de- glycerolized Red Blood Cell under the provisions of Drugs & Cosmetics Act and Rules. M/s. Span Healthcare Pvt. Ltd. Bangalore Biological Division Proposal The firm has presented the case before the committee. After deliberation, the committee recommended for grant of approval of marketing authorization of the proposed product. 8 72/PMS/Novo Nordisk /16BD Turoctocogalfa M/s NovoNordisk India Pvt ltd Form 45 was issued on with the waiver of Phase III clinical trial with the condition to conduct structured Phase IV study in atleast 50 Indian populations and protocol of the same should be submitted before marketing of drug in the country. The protocol was submitted and deliberated in SEC on and committee opined for submission of amended protocol, which the firm has not yet complied and requesting waiver of Phase IV study. The committee has taken a serious note on this lapse and recommended for appropriate action by the Licensing Authority. Further, the waiver of Phase IV study cannot be considered.

6 File /Drug Name Name of firm/ Institute Recommendations /Biocon/17BD Trastuzumab M/s Biocon Limited After detailed deliberation, the committee opined the following: i. This is the same Biosimilar product having some change in the excipients for which a product already exists with the firm and is being marketed. ii. It was also noted there was litigation against the previous Biosimilar product marketed by the firm. iii. The comparability of this product with the innovator and the existing product of the same firm needs to be examined in greater detail by CDSCO before further deliberation by the committee /Hetero/17-BD Trastuzumab M/s. Hetero Drugs Ltd. After detailed deliberation, the committee recommended the conduct of Phase III clinical trial as presented with condition that there will be data of atleast 100 evaluable subjects in the Test arm.