Recommendation:- The 19 th SEC - (Oncology & Hematology) deliberated the proposals on and recommended the following:-

Transcription

1 Recommendation:- The 19 th SEC - (Oncology & Hematology) deliberated the proposals on and recommended the following:- Agend a No. File No. 1. File No.: 12-75/13-DC Afatinib film coated tablet 20/30/40/50mg Name of firm/institute M/s Boehringer Ingelheim India Pvt. Ltd Recommendations The firm has applied for Import and marketing of Afatinib film coated tablet 20/30/40/50 mg to be indicated for treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) with Epidermal Growth Factor Receptor (EGFR) mutation. The proposal was deliberated in SEC (Oncology and Hematology) held on and the Committee deliberated the matter in detail and noted that the data generated in Indian patients is adequate and the firm has also proposed to conduct another study with 50 patients. The Committee recommended for grant of permission for Afatinib film coated tablet 20/30/40/50 mg with indication for treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) with Epidermal Growth Factor Receptor mutation. The proposal was referred to the Committee for re-examination in light of the recommendations on the waiver of Clinical trial in Indian population for approval of New Drugs. reconfirmed that waiver of clinical trial may be granted because this is an orphan drug for the proposed indication the safety data available on 47 Indian patients (including 10 of the same indication) is adequate the efficacy data provided from global studies is adequate Active monitoring of patients receiving the drug post marketing should be done for a period of 2 years and the ADRs reported to PvPI.

2 2. File No.: 12-05/14- DC Enzalutamide 40mg capsule 3. File no:12-121/2008-dc(ptintas) Paclitaxel lipid suspension for injection 30mg/vial & 60mg/vial 4. File no.:12-31/07- dc(pt-a-gsk) Lapatinib Ditosylate tablet 200 mg 5. File no.: 12-07/2013-dc Methylcobalamin M/s Astellas Pharma M/S Intas Pharmaceuticals Ltd. M/s GSK Pharmaceuticals M/s Troikaa Pharmaceuticals The firm applied for permission to Import and Market Enzalutamide 40 mg capsule indicated for the treatment of adult men with metastatic castration resistant prostate cancer whose disease has progressed on or after Docetaxel therapy. recommended that as the drug is an orphan drug for the proposed indication and in order not to delay access to a therapy that has been shown to have adequate efficacy and safety and the drug is already approved for marketing in USA, EU and 47 other countries, marketing authorization may be granted with local clinical trial waiver, subject to conduct of a Phase IV clinical trial in appropriate sample size which includes evaluation of the PK parameters in at least 12 patients. The firm should submit the protocol for Ph-IV trial and PK study with appropriate sample size. After detailed deliberation, the committee opined that as per the independent Bio-statistician s report, the PP analysis shows that the sample size is inadequate to show non inferiority, Hence the committee did not recommend approval for Marketing at this stage. Committee recommended to extend the study so that it achieves a power of 80%; non-inferiority limit of 10%; and an alfa error of 5% for PP and ITT analysis. Additionally the data for progression free survival of the patients should be obtained for further patients. In view of the low bioavailability of the drug and the company s hypotheis of better tissue distribution, tumour tissue levels should also be estimated in at least 12 patients and presented. The committee recommended for the approval for the proposed additional indication as there is no currently available treatment for the patients in the country with hormone receptor-negative metastatic breast cancer whose tumours overexpress HER2/neu (ErbB2 ) and who have progressed on prior Transtuzumab therapy(s) in combination with chemotherapy in the metastatic setting. The committee noted that no formal approval was obtained by the firm for conducting the BA study. Hence the committee did not review the data

3 nasal spray 250mcg/0.05ml 6. File no.: CT/20/14 Masitinib M/s Maya clinical research generated by the firm. Committee also opined that study shall be repeated after obtaining formal approval from the Office of DCG(I). The firm has applied for permission to conduct phase 3 study with Masitinib (100 mg / 200mg Tablets) in treatment of patients with non resectable locally advanced or metastatic pancreatic cancer. At 08 canters in India a total of 80 subjects from India are planned to be enrolled out of Globally 549 subjects in 13 countries which include Italy, Germany, France, Canada, Malaysia, United States and India. The drugs is not approved anywhere in the world. Risk versus Benefit to the patients- The safety profile of the test drug from various pre-clinical studies including single dose, repeat dose, reproduction and development toxicity, genotoxicity and clinical phase I, II, III studies justify the conduct of the study. Innovation vis a vis existing therapeutic option- The purpose of the study is to compare as first line therapy efficacy and safety of masitinib in combination with gemcitabine, to gemcitabine in combination with placebo, followed as second line treatment by masitinib in combination with Folfiri 3 versus placebo in combination with Folfiri 3 in the treatment of patients with non resectable locally advanced or metastatic pancreatic cancer. Unmet need- The test drug may be a better treatment option for treatment of non resectable locally advanced or metastatic pancreatic cancer. recommended that to conduct the trial with proposed protocol. 7. Fileno.: CT/21/14 Masitinib M/s Maya clinical research., Risk versus Benefit to the patients- The safety profile of the test drug from various pre-clinical studies including single dose, repeat dose, reproduction and development toxicity, genotoxicity and clinical phase I, II, III studies justify the conduct of the study. Innovation vis a vis existing therapeutic option-

4 The purpose of the study is to compare the efficacy and safety of masitinib in combination with Folfiri (irinotecan, 5 fluorocil and folinic acid) to placebo in combination with Folfiri in second line treatment with metastatic colorectal cancer. Unmet need- The test drug may be a better treatment option for treatment of with metastatic colorectal cancer. recommended that to conduct the trial with proposed protocol. 8. File no.:ct/22/14 Masitinib M/s Maya clinical research Risk versus Benefit to the patients- The safety profile of the test drug from various pre-clinical studies including single dose, repeat dose, reproduction and development toxicity, genotoxicity and clinical phase I, II, studies justify the conduct of the study. Innovation vis a vis existing therapeutic option- The purpose of the study is to compare efficacy and safety of masitinib in combination with docetaxel to placebo in combination with docetaxel in first line metastatic resistant prostate cancer. Unmet need- The test drug may be a better treatment option for treatment of metastatic resistant prostate cancer. recommended that to conduct the trial with proposed protocol. 9. File no.:4-123/dr. Reddy/12-BD (Part-1) Rituximab Dr. Reddy s Laboratories SEC meeting and the SEC committee opined that the firm may be permitted to amend the proposed changes in the protocol. However the concern raised by the SEC regarding inclusion of patients having T rich cell B- Lymphomas in this group of otherwise homogenous group of DLBCL patients should be further considered by the firm. Accordingly the firm is required to submit revised

5 10. File no: 4-254/Hetero/14-BD Bevacizumab M/s Hetero drugs ltd. protocol to this office and after satisfactory compliance permission may given to the firm without further deliberation in subsequent SEC meeting. SEC meeting and the SEC committee opined that the firm is required to modify the protocol to include the following additional safety and efficacy steps in the study: Documentation of infusional toxicity as well as PK and relevant PD data in the first 15 patients (10 test drug and 5 comparator molecule). This is to be reviewed by the DSMB before proceeding with recruitment of further patients in the study. An interim analysis should also be included in the study at a suitable point to be reviewed by the DSMB. The Phase III clinical trial permission may be granted to the firm after satisfactory compliance to the above noted recommendation by this office without further SEC deliberation. 11. File no:4-220/baxter/13-bd Recombinate Antihaemophilic factor IX 12. File no.: 6-5/BP- 39/10-BD Human Normal Immunoglobulin (Human IVIg), Triple Virally Reduced (TVR) Solution for injection (Intravenous) M/s Baxter (India) Pvt.Ltd. M/s Baxter (India) Pvt.Ltd. SEC meeting and the SEC committee opined that in view of the facts that there is adequate safety and efficacy data from global clinical trials as well as post marketing use in patients, that this drug would qualify as an orphan drug in India and there is an unmet need in the country for FIX factor concentrate, marketing authorization may be given for the drug Recombinant anti haemophilic factor IX with a waiver for local clinical trial. The committee opined that this being a proposal for approval of a neurological indication, an appropriate committee should evaluate it, SEC (Neurology).

6 13. File no.: 4-275/Reliance life sci.pvt.ltd/14bd Peg-Filgrastim M/s Reliance life sciences SEC meeting and the SEC committee opined that The PK/PD study may be permitted for export purpose.