Item 8.01. Other Events.
OnSeptember 19, 2022 ,BeiGene, Ltd. ("BeiGene") announced that the Committee for Medicinal Products for Human Use of theEuropean Medicines Agency has issued a positive opinion recommending approval of BRUKINSA® (zanubrutinib) for the treatment of adult patients with marginal zone lymphoma who have received at least one prior anti-CD20-based therapy. The full text of this press release is filed as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference. OnSeptember 20, 2022 ,BeiGene announced thatEngland's health technology assessment institute, theNational Institute for Health and Care Excellence , has issued a final appraisal document recommending BRUKINSA® (zanubrutinib) for the treatment of Waldenström's Macroglobulinemia in adults who have had at least one treatment, only if bendamustine plus rituximab is also suitable. The full text of this press release is filed as Exhibit 99.2 to this Current Report on Form 8-K and is incorporated herein by reference.
Item 9.01. Financial Statements and Exhibits.
(d) Exhibits. Exhibit No. Description 99.1 Press release titled "BeiGene Receives Positive
CHMP Opinion for BRUNKINSA®
(zanubrutinib) for the Treatment of Adults with
Marginal Zone Lymphoma" issued
byBeiGene onSeptember 19, 2022 99.2 Press release titled "NICE Recommends BeiGene's
BRUKINSA® (zanubrutinib) for
Patients with Waldenström's Macroglobulinemia who
have at least One Treatment"
issued byBeiGene, Ltd. onSeptember 20, 2022 104 The cover page from this Current Report on Form 8-K, formatted in Inline XBRL
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