Recommendations of the SEC (Oncology & Haematology) made in its 95th meeting

held on 13.03.2020 at CDSCO HQ New Delhi:

Agenda File Name & Drug Firm Name Recommendations

No Name, Strength
New Drugs Division
1. ND/CT/20/000001 M/s. Sun The firm presented their proposal
Bosutinib tablets Pharmaceutic along with the protocol for Phase IV
al Industries study.
Limited
After detailed deliberation, the
committee recommended for grant of
permission to conduct the proposed
Phase IV study with the following
changes:
1. At least 50% of patients to be
enrolled should be resistant
CML.
2. The drug should be provided
free of cost in the responders
till progression even after
completion of planned study
as part of post trial access as
per rules.
2. 12-01/19-DC(PU-48) M/s. The firm didn’t turn up for the
Nintedanib Capsule Boehringer presentation.
100 & 150 mg Ingelheim
India Pvt
3. 12-01/19-DC(PU-38) M/s. Sandoz The firm presented their proposal
Midostaurin capsules Private along with the proposed update in the
25 mg limited package insert.

After detailed deliberation the

committee recommended for
approval for the proposed update of
package insert.

Further, the committee also opined

that the updation should be applicable
to all other manufacturers / importer
of Midostaurin capsules 25 mg.
4. 12-01/19-DC (Pt- M/s. Pfizer The firm presented the protocol of the
267) Limited proposed study claiming it as an
Palbociclib observational study.
After detailed deliberation, the
committee opined that it is an
observational study and there may be
no objection for conduct of the study.
5. 12-01/12-DC (Pt- Internal After detailed deliberation, the
Doxifluridine) Discussion committee recommended that further
information in respect to present
regulatory status in other countries as
well as details regarding clinical use
of the drug in the country including
its Manufacturers/Importers, if any,

95th SEC (Oncology & Haematology) 13.03.2020

Agenda File Name & Drug Firm Name Recommendations
No Name, Strength
may be collected for further
consideration.

Biological Division
6. 4-16/DRL/PAC-R- M/s. Dr. The firm presented their proposal for
Denosumab(Xgeva)/ Reddy’s updation in prescribing information
18-BD Laboratories based on global clinical studies.
Denosumab solution Ltd After detailed deliberation, the
for injection, 120mg committee recommended that the
(70mg/mL) firm should submit the detailed
justification and data in support of its
claim regarding association of
atypical femoral fractures occurring
up to 9 months and not beyond from
stoppage of the drug.
7. In light of the recommendation of the
SEC in the meeting dated 06.11.2019,
the firm presented justification on the
4-55/Intas/PAC-R-
basis of data on average Indian body
Trastuzumab(375mg
M/s. Intas weight.
)/19-BD
Pharmaceutic The committee noted that the
Trastuzumab
als Limited justification/data presented are old.
(375mg/vial)
After detailed deliberation, the
committee did not recommend for
approval of the proposed additional
pack size.
8. Firm presented their proposal along
with Phase I & II Clinical Trial data
from other country for import and
marketing authorization of
Crizanlizumab with local clinical trial
waiver.
The committee noted that the drug is
approved in USA with breakthrough
designation and Brazil. Further, there
BIO/IMP/19/000070 is an unmet need for the proposed
Crizanlizumab indication.
M/s. Sandoz
Concentrate for After detailed deliberation, the
Private
solution for infusion committee recommended for grant of
Limited
10 mg/mL (100 permission to import and market the
mg/10 mL) drug with local Phase III clinical trial
waiver subject to the condition that
the firm shall conduct Phase IV
clinical trial in the country and the
protocol should be submitted within 3
months from the date of approval.

Further, the firm should present the

data of ongoing global Phase III
clinical trial after completion.
9. BIO/CT18/FF/2019/ M/s. Applicant presented their proposal
16912 AstraZeneca for approval of drug for additional
Durvalumab Pharma India indication before the committee.

95th SEC (Oncology & Haematology) 13.03.2020

Agenda File Name & Drug Firm Name Recommendations
No Name, Strength
Limited The new proposed indication is yet
to be approved in key countries.
The committee after detailed
deliberation recommended that firm
should submit the detailed data of
safety & efficacy of drug including
the PMS data in approved indication
from other countries.
Committee also noted that Protocol
approval for Phase IV clinical trial
which was required to be conducted
within 2 years in India for approved
indication has not even been
obtained. Therefore, appropriate
measures may be taken by CDSCO.
GCT Division
10. CT/13/20 M/s. Applicant presented their proposal for
Osimertinib AstraZeneca global clinical trial before the
committee.

Assessment of risk vs. Benefit to the

patients: The potential benefits of
Osimertinib from the preclinical,
clinical trials supports the conduct of
the study.

Innovation vis-à-vis Existing

Therapeutic option: To evaluate the
efficacy, safety, tolerability and
pharmacokinetics of osimertinib plus
chemotherapy treatment compared
with osimertinib.

Unmet Medical Need In The

Country: Treatment of Patients with
Epidermal Growth Factor Receptor
(EGFR) Mutation-Positive, Locally
Advanced or Metastatic Non-small
Cell Lung Cancer.

After detailed deliberation the

committee recommended for grant
of permission to conduct the trial.

11. CT/01/20 M/s. JSS The firm presented their proposal

Devimistat Medical for global clinical trial before the
Research committee.

Assessment of Risk versus benefit to

the patients- The safety profile of the
study drug from preclinical and clinical
studies justify the conduct of the trial.

95th SEC (Oncology & Haematology) 13.03.2020

Agenda File Name & Drug Firm Name Recommendations
No Name, Strength
Innovation vis-a-vis existing
therapeutic- To Evaluate Efficacy
and Safety of CPI-613®
(devimistat) in Combination with
High Dose Cytarabine and
Mitoxantrone (CHAM) Compared
to High Dose Cytarabine and
Mitoxantrone (HAM) in Older
Patients (≥ 50 years) with
Relapsed/Refractory Acute Myeloid
Leukemia (AML).

Unmet medical need in the

country- The test drug used for
treatment with Relapsed/Refractory
Acute Myeloid Leukemia (AML) an
unmet medical need.

After detailed deliberation, the

committee recommended for grant
of permission to conduct the trial.

12. CT/10/20 M/s. Novo- The firm presented their proposal

Concizumab Nordisk for global clinical trial before the
committee.

Assessment of risk vs. Benefit to the

patients: The safety profile of the
study drugs from preclinical
toxicology studies including 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 assess the efficacy of
Concizumab prophylaxis in patients
with haemophilia A and B, with or
without inhibitors
Unmet Medical need in the
country: The test drug may
potentially provide Treatment in
patients with haemophilia A and B,
with or without inhibitors

After detailed deliberation the

committee recommended for grant
of permission to conduct the trial.

95th SEC (Oncology & Haematology) 13.03.2020

13. CT/16/20 M/s. Novartis Applicant presented their study
CMML-2 proposal 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 effect
and safety ofazacitidine with or
without MBG453 for the treatment of
patients with intermediate, high or
very high risk myelodysplastic
syndrome (MDS) as per IPSS-R, or
Chronic Myelomonocytic Leukemia-
2 (CMML-2).
Unmet medical need in the
country- To develop efficacious
treatment for high or very high risk
myelodysplastic syndrome (MDS) as
per IPSS-R, or Chronic
Myelomonocytic Leukemia-2
(CMML-2).

After detailed deliberation the

committee recommended for grant
of permission to conduct the study.

95th SEC (Oncology & Haematology) 13.03.2020