Nov 29, 2021 | Business
Eisai Co., Ltd. and Merck & Co., Inc., Kenilworth, N.J., U.S.A. (known as MSD outside the United States and Canada) today announced that the European Commission has approved the combination of LENVIMA, the orally available multiple receptor tyrosine kinase inhibitor discovered by Eisai, plus KEYTRUDA, the anti-PD-1 therapy from Merck & Co., Inc., Kenilworth, N.J., U.S.A., for the treatment of advanced or recurrent endometrial carcinoma in adults who have disease progression on or following prior treatment with a platinum containing therapy in any setting and who are not candidates for curative surgery or radiation. This marks the first combination of tyrosine kinase inhibitor with immunotherapy approved in Europe for these patients with advanced or recurrent endometrial carcinoma.
The approval is based on results from the pivotal Phase 3 Study 309/KEYNOTE-775 trial, in which LENVIMA plus KEYTRUDA demonstrated statistically significant improvements in overall survival (OS), reducing the risk of death by 38% (HR=0.62 [95% CI, 0.51-0.75]; p
“This approval is welcome news for patients in Europe, and is based on the first Phase 3 study evaluating an immunotherapy and tyrosine kinase inhibitor combination that showed superior overall survival for patients with advanced or recurrent endometrial cancer compared to chemotherapy,” said Dr. Gregory Lubiniecki, Vice President, Clinical Research, Merck & Co., Inc., Kenilworth, N.J., U.S.A. Research Laboratories. “Regardless of mismatch repair status, patients whose endometrial cancer progresses or returns after prior platinum-containing systemic therapies now have a combination treatment option in KEYTRUDA plus LENVIMA that demonstrated a 38% reduction in risk of death compared to chemotherapy alone.”
“Until recently, women in Europe with advanced or recurrent endometrial cancer have faced a difficult prognosis and had few treatment options,” said Corina Dutcus, M.D., Vice President, Clinical Research, Oncology Business Group at Eisai Inc. “The approval of LENVIMA plus KEYTRUDA in this setting reflects the progress that we have made in our collaboration with Merck & Co., Inc., Kenilworth, N.J., U.S.A. in developing solutions for those diagnosed with difficult-to-treat cancers. We thank the patients, families and healthcare providers who made this milestone possible.”
In the Study 309 trial, the most common adverse reactions of these patients (>/=20%) for LENVIMA plus KEYTRUDA* were hypertension (63%), diarrhoea (57%), hypothyroidism (56%), nausea (51%), decreased appetite (47%), vomiting (39%), fatigue (38%), decreased weight (35%), arthralgia (33%), proteinuria (29%), constipation (27%), headache (27%), urinary tract infection (27%), dysphonia (25%), abdominal pain (23%), asthenia (23%), palmar-plantar erythrodysaesthesia syndrome (23%), stomatitis (23%), anaemia (22%), and hypomagnesaemia (20%).
This approval allows marketing of LENVIMA plus KEYTRUDA in all 27 EU member states plus Iceland, Liechtenstein, Norway and Northern Ireland. LENVIMA plus KEYTRUDA is now approved by the European Commission for two different types of cancer: for advanced or recurrent endometrial carcinoma in adults who have disease progression on or following prior treatment with a platinum containing therapy in any setting and who are not candidates for curative surgery or radiation and for the first-line treatment of adult patients with advanced renal cell carcinoma.
*According to the information listed in the SmPC (Summary of Product Characteristics)
For more information, visit https://www.eisai.com/news/2021/news202193.html.
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Nov 14, 2021 | Business
The Commission for Air Quality Management in NCR and Adjoining Areas (CAQM) convened a crucial meeting on an emergent basis today in wake of deteriorating air quality of the Delhi-NCR region. Apart from the order issued on 13.11.2021 after the 8th meeting of the Sub-Committee for GRAP, detailing various air pollution preventive measures and mitigation actions that need to be undertaken by the various agencies concerned across Delhi-NCR, the GRAP order has also advised States and concerned agencies to be in complete readiness for implementing ‘Emergency Measures’ as listed under Graded Response Action Plan (GRAP).
The adverse air quality scenario in Delhi-NCR as a combined result of paddy stubble burning, vehicular pollution, post-Diwali pollution, dip in temperature and other local factors, was also greatly impacted by a dust storm moving in from the South-Westerly directions of the Thar desert which brought in huge quantities of dust that further amplified the PM2.5 / PM10 levels significantly. Considering all different aspects causing a spike in the air pollution levels, the Commission during the meeting reiterated that the actions recommended by the orders of the Sub-Committee, shall be strictly implemented by the States.
The Commission has also identified 5 different areas contributing to the prevailing adverse air quality of Delhi-NCR that need better focus with intensified efforts by the concerned agencies of the State Governments of National Capital Region (NCR) and GNCTD. These areas are:
- Control of paddy stubble burning incidences;
- Control of dust from Construction and Demolition (C&D) activities;
- Control of dust from roads and open areas;
- Vehicular Pollution; and
- Industrial Pollution
CAQM has pulled out all the stops in the battle against air pollution. The Commission, from time to time, has been advising various policy initiatives and actions directed towards improvement of air quality in the region. From issuing 43 Directions and 7 Advisories to regularly holding meetings with the concerned departments of the State Governments and other concerned agencies of NCR, CAQM has been pro-actively taking stock of efforts taken by the respective states towards abatement of air pollution.
CAQM is of the view that there is a vital need for regular assessments by senior level management in the State Governments and the agencies concerned so as to be well aware of the visible impact of the efforts initiated on-ground towards improvement of air quality in Delhi-NCR.
While soliciting views from the State Governments of Haryana, Rajasthan and Uttar Pradesh (U.P.), the Commission advised the concerned departments to consider similar restrictions/ regulations in the respective NCR districts as implemented by GNCTD through its order on 13.11.2021 which includes, inter alia, closure of schools up to 20th November, 2021 and closure of C&D activities from 14th – 17th November.
Further, the State Governments and District Administrations in the NCR States were also suggested to issue a Citizen Charter / Advisory for general public including various steps that need to be taken during various stages/ categories of the GRAP Action Plan. The Commission also reiterated the need for extra vigilance and concerted measures in various sectors that immediately and adversely impact the air quality.
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(Release ID: 1771727)
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