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Recommendations of the SEC (Oncology & Haematology) made in its 58thmeeting held on 22.08.2017 at CDSCO HQ New Delhi:

Age File no./Drug Name Name of firm/ Recommendations nda Institute no.

Global Clinical Trials Division

1 CT/52/17 M/s. Roche The firm presented the pre-clinical, clinical data Atezolizumab and Phase-III trial protocol etc. Assessment of Risk vs. Benefit to the patients: The safety profile of the study drugs from preclinical toxicology studies including repeated dose toxicity, local tolerance and clinical studies justify the conduct of the trial

Innovation vis-à-vis Existing Therapeutic Option: To evaluate the efficacy of atezolizumab compared with single agent in patients with treatment-naïve locally advanced or metastatic NSCLC who are deemed unsuitable for platinum-containing therapy, as measured by overall survival (OS).

Unmet Medical Need in the country: The test drug may potentially provide alternative treatment option for subjects with treatment- naïve advanced or recurrent (Stage IIIB not amenable for multimodality treatment) or metastatic (Stage IV) Non-Small Cell Lung Cancer who are deemed unsuitable for platinum-containing therapy.

After the detailed deliberation, the committee recommended for grant of permission to conduct the .

2 CT/54/17 M/s. Novotech The firm did not turn up for the Dinutuximab presentation. Injection 3 CT/40/17 M/s. Eli Lilly The firm presented the pre-clinical, clinical data Abemaciclib and Phase-III trial protocol etc. Assessment of Risk vs. Benefit to the patients: The safety profile of the study drugs from preclinical toxicology studies including repeated dose toxicity, Female Reproduction, Developmental Toxicity Studies and clinical studies Phase I/II justify the conduct of the trial Innovation vis-à-vis Existing Therapeutic Option: To evaluate the efficacy of abemaciclib plus adjuvant endocrine therapy versus adjuvant endocrine therapy alone in patients with HR+, HER2- early stage , in terms of IDFS Unmet Medical Need in the country: The test drug may potentially provide alternative

58thSEC (Oncology & Haematology)_22.08.2017 Age File no./Drug Name Name of firm/ Recommendations nda Institute no.

treatment option for subjects with High Risk, Node Positive, Early Stage, Hormone Receptor Positive, Human Epidermal Receptor 2 Negative, Breast Cancer. After the detailed deliberation, the committee recommended for grant of permission to conduct the clinical trial.

Biological Division

4 4-426/ Biocon/ 17-BD M/s.Biocon The firm has applied for a blanket Peg-Filgratsim (r- Limited permission to obtain license to manufacture DNA Origin) solution the Drug substance and drug product for Injection 6mg/ 0.6 exclusively for export purposes. The firm mL in a pre-filled had conducted clinical trial, PK & PD study syringe. in some EU countries. After detailed deliberations the Committee opined that since the product is meant exclusively for export purposes, action may be taken by CDSCO as per the existing policy

5 4-425/ Cadila/17-BD M/s.Cadila The firm presented the Phase-III trial protocol Inj. Healthcare Ltd. as per the earlier recommendation. After the detailed deliberation, the committee recommended for grant of permission to conduct the Phase –III clinical trial in patients with Diffuse large B-Cell lymphoma (DLBCL).

6 72/PMS/Novo M/s. Novo The firm presented the Phase-IV trial protocol Nordisk Nordisk India incorporating all recommendation of earlier Turoctogalfa (Factor Pvt Ltd SEC meeting dated 28/6/2016. VIII, recombinant) After detailed deliberations the committee recommended for the approval of the revised protocol. 7 4-129/ GSK/12-BD M/s. GSK The firm presented their request to stop Pharmaceuticals further recruitment in the ongoing Phase IV clinical trial with justification citing difficulties in recruiting subjects. After detailed deliberation the committee opined that, the firm should complete the study and submit the data on 50 patients. Subsequent New Drugs Division

8 12-60/2017-DC (pt- Firm presented the proposal before Novartis-snd) committee. The committee opined that “non capsule small cell lung cancer with a BRAF V600 M/s. Novartis 50mg/75mg (add. mutation”which is a very rare disease Indication) condition. After detailed deliberation the committee

58thSEC (Oncology & Haematology)_22.08.2017 Age File no./Drug Name Name of firm/ Recommendations nda Institute no.

recommended for grant of permission to market the drug for the proposed indication. The firm should follow up every patient treated with the drug to capture the safety and efficacy profile and submit the sameevery six months for four years. 9 12-62/2017-DC (pt- Firm presented the proposal before Novartis-snd) committee. The committee opined that “non small cell lung cancer with a BRAF V600 0.5mg/2mg tablet mutation” which is a very rare disease (add. Indication) condition. After detailed deliberation the committee M/s. Novartis recommended for grant of permission to market the drug for the proposed indication. The firm should follow up every patient treated with the drug to capture the safety and efficacy profile and submit the same every six months for four years. 10 12-92/2016-DC (pt- Firm presented their proposal along with Rasayani-snd) multiple dose study protocol 3,6,9 before the committee. % 12mg capsule (Add After detailed deliberation the committee strength dosage form) M/s. recommended that the firm should first RasayaniBiologi conduct comparative single dose bio cals Ltd. availability/bioequivalence study with two oral dose levels of 9mg & 12mgvis-a-vis I.V dose. Accordingly revised bioavailability study protocol to be submitted for review by the committee.

58thSEC (Oncology & Haematology)_22.08.2017