checkAd

Seagen and Genmab Announce FDA Accelerated Approval for TIVDAK (tisotumab vedotin-tftv) in Previously Treated Recurrent or Metastatic Cervical Cancer

Nachrichtenquelle: Business Wire (engl.)
20.09.2021, 23:00  |  118   |   |   

Seagen Inc. (Nasdaq: SGEN) and Genmab A/S (Nasdaq: GMAB) today announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval to TIVDAK (tisotumab vedotin-tftv), the first and only approved antibody-drug conjugate (ADC) for the treatment of adult patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy. TIVDAK is approved under the FDA’s Accelerated Approval Program based on tumor response and the durability of the response. Continued approval may be contingent upon verification and description of clinical benefit in confirmatory trials.1

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210920005921/en/

40 mg vial and carton (Photo: Business Wire)

40 mg vial and carton (Photo: Business Wire)

“Once recurrent or metastatic cervical cancer progresses, there is a need for more options for these patients,” said Robert L. Coleman, M.D., Chief Scientific Officer, US Oncology Research and lead investigator of the innovaTV 204 clinical trial. “This is an important development for patients with recurrent or metastatic cervical cancer.”

In the innovaTV 204 clinical trial, TIVDAK was evaluated in 101 patients with recurrent or metastatic cervical cancer who had received no more than two prior systemic regimens in the recurrent or metastatic setting, including at least one prior platinum-based chemotherapy regimen. Results from the trial showed a 24 percent confirmed objective response rate (ORR) (95% CI; 15.9-33.3), as assessed by an independent review committee (IRC) using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria. The median duration of response (DOR) was 8.3 months (95% CI; 4.2 to not reached).

The prescribing information for TIVDAK includes a BOXED WARNING for ocular toxicity, and Warnings for peripheral neuropathy, hemorrhage, pneumonitis, and embryo-fetal toxicity. The most common (≥25%) adverse reactions, including laboratory abnormalities, were hemoglobin decreased (52%), fatigue (50%), lymphocytes decreased (42%), nausea (41%), peripheral neuropathy (39%), alopecia (39%), epistaxis (39%), conjunctival adverse reactions (37%), hemorrhage (32%), leukocytes decreased (30%), creatinine increased (29%), dry eye (29%), prothrombin international normalized ratio increased (26%), activated partial thromboplastin time prolonged (26%), diarrhea (25%), and rash (25%). Please see Important Safety Information below.1

Seite 1 von 7
Seagen Aktie jetzt über den Testsieger (Finanztest 11/2020) handeln, ab 0 € auf Smartbroker.de



Wertpapier



0 Kommentare

Schreibe Deinen Kommentar

Bitte melden Sie sich an, um zu kommentieren. Anmelden | Registrieren

 

Disclaimer

Seagen and Genmab Announce FDA Accelerated Approval for TIVDAK (tisotumab vedotin-tftv) in Previously Treated Recurrent or Metastatic Cervical Cancer Seagen Inc. (Nasdaq: SGEN) and Genmab A/S (Nasdaq: GMAB) today announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval to TIVDAK (tisotumab vedotin-tftv), the first and only approved antibody-drug conjugate (ADC) …

Community

Nachrichten des Autors

Titel
Titel
Titel
Titel

Nachrichten zu den Werten

DatumTitel
12.10.21Seagen and Astellas Complete Enrollment in EV-103 Trial Cohort K Combining PADCEV (enfortumab vedotin-ejfv) With Pembrolizumab as First-Line Treatment for Advanced Urothelial Cancer
Business Wire (engl.) | Weitere Nachrichten
07.10.21Seagen to Host Conference Call and Webcast Discussion of Third Quarter 2021 Financial Results on October 28, 2021
Business Wire (engl.) | Weitere Nachrichten
28.09.21Seagen Announces Last Patient Enrolled in Phase 2 MOUNTAINEER Trial Evaluating TUKYSA (Tucatinib) Regimen in HER2-Positive Metastatic Colorectal Cancer
Business Wire (engl.) | Weitere Nachrichten
27.09.21Japan’s MHLW Approves PADCEV (enfortumab vedotin) for Advanced Urothelial Cancer
Business Wire (engl.) | Weitere Nachrichten
25.09.21Chartgalerie - Top / Flop Aktien Wochenrückblick Kalenderwoche 38/21
w:o Chartvergleich | Chartanalysen
20.09.21Seagen to Host Conference Call and Webcast Discussion on September 21, 2021 to Discuss TIVDAK (tisotumab vedotin-tftv) Approval
Business Wire (engl.) | Weitere Nachrichten
20.09.21Genmab and Seagen Announce FDA Accelerated Approval for TIVDAK (tisotumab vedotin-tftv) in Previously Treated Recurrent or Metastatic Cervical Cancer
Business Wire (engl.) | Weitere Nachrichten
19.09.21Seagen and Genmab Present Interim Results From the innovaTV 205 Study for Tisotumab Vedotin Combination Therapy Treatment of Recurrent or Metastatic Cervical Cancer at ESMO Virtual Congress 2021
Business Wire (engl.) | Weitere Nachrichten