Page 168 - CW E-Magazine (29-10-2024)

Special Report

Clarivate analysis. A common upper approved setting and lead to label expan- gastric or GEJ adenocarcinoma, according
respiratory infection that can result in sions in other multiple myeloma patient to Clarivate.
hospitalizations in severe cases, RSV populations, including in combination
infection tends to be seasonal and pre- with other approved agents, according In January 2024, Astellas had a set-
sent with symptoms similar to those of to Clarivate. Talquetamab is poised as back for the drug when the FDA issued
infl uenza and COVID-19. The fi rst ap- an important addition to the treatment, a Complete Response Letter due to un-
provals of RSV vaccines (GSK’s Arexvy armamentarium. resolved defi ciencies following its pre-
and Pfi zer’s Abrysovo), respectively license inspection of a third-party manu-
indicated for older adults and infants, Zolbetuximab by Astellas Pharma facturing facility for zolbetuximab. The
represent a signifi cant public health Astellas’ zolbetuximab targets a diffi - company said that FDA did not raise any
milestone, notes Clarivate. cult-to treat disease, metastatic HER2- concerns related to the clinical data, in-
negative gastric and gastroesophageal cluding effi cacy or safety, of zolbetuxi-
Talvey (talquetamab) by Johnson & junction (GEJ) adenocarcinoma (a rare mab, and is not requesting additional
Johnson type of cancer of the oesophagus). In clinical studies. Astellas said in a January
After receiving conditional and contrast to HER2-positive disease, for 2024 statement that it was working
accelerated approval from the European which HER2-targeted agents, such as with FDA and the third-party manufac-
Commission and FDA, respectively, Roche’s Herceptin (trastuzumab] and turer to establish a timeline to resolve
talquetamab became the fi rst-in-class Daiichi Sankyo’s Enhertu (trastuzumab the agency’s feedback, and in late May
bispecifi c antibody targeted to CD3 and deruxtecan), are available, targeted 2024, the company reported that the
GPRC5D to treat multiple myeloma. treatment options are more limited for FDA had accepted the resubmission
It was approved for heavily pretreated HER2-negative patients. Zolbetuximab of its biologics license application for
patients with relapsed or refractory would address some of that unmet need the drug. The FDA has set a new target
multiple myeloma. Ongoing Phase III as a fi rst-in-class claudin 18.2 inhibi- action date of November 9, 2024. A deci-
trials are expected to provide confi rma- tor in oncology as well as a fi rst-line sion on the EU marketing authorization
tion of clinical benefi t in talquetamab’s treatment for metastatic HER2-negative is expected by October 2024.

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168 Chemical Weekly October 29, 2024

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