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LORBRENA (lorlatinib) sNDA in Previously Untreated ALK-Positive Lung Cancer Accepted for Priority Review by U.S. FDA

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Pfizer Inc. (NYSE:PFE) today announced that the U.S. Food and Drug Administration (FDA) has accepted for Priority Review the supplemental New Drug Application (sNDA) for LORBRENA
® (lorlatinib) as a first-line treatment for people with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC). The sNDA is based on data from the pivotal CROWN study and is being reviewed by the FDA under its Real-Time Oncology Review (RTOR) pilot program. The Prescription Drug User Fee Act (PDUFA) goal date for a decision by the FDA is in April 2021.
LORBRENA is a third-generation ALK inhibitor specifically developed to inhibit the most common tumor mutations that drive resistance to current medications and to address brain metastases. Up to 40% of people with ALK-positive lung cancer present with brain metastases. ....

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LORBRENA® (lorlatinib) sNDA in Previously Untreated ALK-Positive Lung Cancer Accepted for Priority Review by U.S. FDA

Press release content from Business Wire. The AP news staff was not involved in its creation.
LORBRENA® (lorlatinib) sNDA in Previously Untreated ALK-Positive Lung Cancer Accepted for Priority Review by U.S. FDA
December 28, 2020 GMT
NEW YORK (BUSINESS WIRE) Dec 28, 2020
Pfizer Inc. (NYSE:PFE) today announced that the U.S. Food and Drug Administration (FDA) has accepted for Priority Review the supplemental New Drug Application (sNDA) for LORBRENA ® (lorlatinib) as a first-line treatment for people with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC). The sNDA is based on data from the pivotal CROWN study and is being reviewed by the FDA under its Real-Time Oncology Review (RTOR) pilot program. The Prescription Drug User Fee Act (PDUFA) goal date for a decision by the FDA is in April 2021. ....

United States , United Kingdom , South Korea , Steven Danehy , Chris Boshoff , Bryan Dunn , Peterss Alectinib , Kantar Health , Decision Resource Group , Time Oncology Review Pilot Program , Pfizer Inc , International Agency For Research On Cancer , European Union , Virtual Congress , American Cancer Society , Drug Administration , World Health Organization , Pfizer Global Product Development , Exchange Commission , European Society For Medical Oncology , Priority Review , New Drug Application , Real Time Oncology Review , Prescription Drug User Fee Act , Chief Development Officer , Pfizer Global Product ,

BAVENCIO® (avelumab) Receives Positive CHMP Opinion for First-Line Maintenance Treatment of Locally Advanced or Metastatic Urothelial Carcinoma

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14-Dec-2020
BAVENCIO® (avelumab) Receives Positive CHMP Opinion for First-Line Maintenance Treatment of Locally Advanced or Metastatic Urothelial Carcinoma
Feltham (Merck) & Walton Oaks (Pfizer) – Merck and Pfizer today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion recommending approval of BAVENCIO
® (avelumab) as monotherapy for the first‑line maintenance treatment of adult patients with locally advanced or metastatic urothelial carcinoma (UC) whose disease has not progressed with platinum‑based induction chemotherapy. The CHMP positive opinion will now be reviewed by the European Commission (EC), with a decision expected in early 2021. ....

United States , United Kingdom , Chris Boshoff , Simon Crabb , Feltham Merck Walton Oaks , Pfizer Alliance , Merck Press , European Commission , Pfizer Global Product Development , Merck Kga , University Of Southamptonexplains , Merck Kgaa , European Medicines Agency , Global Head Of Development For The Biopharma , Committee For Medicinal Products Human Use , Walton Oaks , Medicinal Products , Human Use , New England Journal , Associate Professor , Medical Oncology , Danny Bar Zohar , Global Head , Chief Development Officer , Pfizer Global Product , Product Characteristics ,

BAVENCIO® (avelumab) Receives Positive CHMP Opinion for First-Line Maintenance Treatment of Locally Advanced or Metastatic Urothelial Carcinoma

BAVENCIO® (avelumab) Receives Positive CHMP Opinion for First-Line Maintenance Treatment of Locally Advanced or Metastatic Urothelial Carcinoma
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BAVENCIO® Receives Positive CHMP Opinion for First-Line Maintenance Treatment of Locally Advanced or Metastatic Urothelial Carcinoma

EMD Serono, the biopharmaceutical business of Merck KGaA, Darmstadt, Germany in the US and Canada and Pfizer Inc. today announced that the Committee for Medicinal Products for Human Use of the European Medicines Agency adopted a positive opinion recommending approval of BAVENCIO ® as monotherapy for the first-line maintenance treatment of adult patients with locally advanced or metastatic urothelial carcinoma who …
– EMD Serono, the biopharmaceutical business of Merck KGaA, Darmstadt, Germany in the US and Canada and Pfizer Inc. (NYSE: PFE) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion recommending approval of BAVENCIO ® (avelumab) as monotherapy for the first-line maintenance treatment of adult patients with locally advanced or metastatic urothelial carcinoma (UC) who are progression-free following platinum-based chemotherapy. The CHMP positive opinion will now be reviewe ....

New York , United States , Chris Boshoff , Bryan Dunn , Noelle Piscitelli , Steve Danehy , Group Website , Serono Inc , Merck Kga , Pfizer Inc , Global Head Of Development For The Biopharma , Committee For Medicinal Products Human Use , American Cancer Society , Pfizer Alliance , Drug Administration , European Commission , Pfizer Global Product Development , Exchange Commission , Merck Kgaa , European Medicines Agency , Medicinal Products , Human Use , New England Journal , Chief Development Officer , Pfizer Global Product , Danny Bar Zohar ,