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Home » Topics » Regulatory

Regulatory
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NMPA clears Alpha’s oral EGFR-TKI for NSCLC with brain metastases

Nov. 21, 2024
By Marian (YoonJee) Chu
China’s drug regulator approved Alpha Biopharma Ltd.’s EGFR tyrosine kinase inhibitor (TKI), Zorifer (zorifertinib hydrochloride tablets; AZD-3759), as a first-line treatment for EGFR-mutated non-small-cell lung cancer (NSCLC) with brain metastases.
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Illustration of cancer in the bile ducts

FDA approves biliary tract cancer treatment from Jazz

Nov. 21, 2024
By Lee Landenberger
More than a week ahead of its priority PDUFA date, the U.S. FDA has greenlit the first dual HER2-targeted bispecific antibody specifically for previously treated, unresectable or metastatic HER2-positive biliary tract cancer. The approval went to Jazz Pharmaceuticals plc for Ziihera (zanidatamab), an injection given to adults every two weeks. The treatment was designed to have a more favorable profile than competitors, where drugs targeting HER2 such as Astrazeneca plc’s Enhertu (trastuzumab deruxtecan) and Roche Holding AG’s Herceptin (trastuzumab) are options, as well as checkpoint inhibitors such as Merck & Co Inc.’s Keytruda (pembrolizumab).
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Hidradenitis suppurativa illustration

UCB chalks hidradenitis suppurativa as fifth indication for Bimzelx

Nov. 20, 2024
By Randy Osborne
The U.S. FDA added hidradenitis suppurativa to the label for UCB SA’s Bimzelx (bimekizumab-bkzx), throwing renewed light on the indication, a chronic disease that causes painful, boil-like lumps that appear under the skin. Regulators cleared the humanized IL-17A and IL-17F antagonist for adults with moderate to severe HS, marking the drug’s fifth approval.
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Hepatitis B virus rendering
Infection

Epigenic Therapeutics’ epigenetic inactivator cleared to enter clinic for chronic hepatitis B

Nov. 20, 2024
Epigenic Therapeutics Inc. has received clinical trial application (CTA) approval from the New Zealand Medicines and Medical Devices Safety Authority (Medsafe) and the Health and Disability Ethics Committees (HDEC) to initiate a clinical trial for EPI-003, an investigational, liver-targeting antiviral therapy for chronic hepatitis B virus (HBV) infection.
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Illustration of siRNA structure
Neurology/psychiatric

Ractigen Therapeutics’ RAG-21 designated orphan drug for ALS

Nov. 20, 2024
Ractigen Therapeutics Co. Ltd.’s RAG-21, a novel siRNA therapy targeting the FUS gene, has been awarded orphan drug designation by the FDA for the treatment of amyotrophic lateral sclerosis (ALS).
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Neurology/psychiatric

Sangamo’s ST-503 receives IND clearance for idiopathic small fiber neuropathy

Nov. 20, 2024
Sangamo Therapeutics Inc. has received IND clearance from the FDA for ST-503, an investigational epigenetic regulator for the treatment of intractable pain due to idiopathic small fiber neuropathy (iSFN).
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Daiichi Sankyo, Astrazeneca submit new BLA for Trop2 lung cancer ADC

Nov. 19, 2024
By Tamra Sami
Daiichi Sankyo Co. Ltd. and Astrazeneca plc have submitted a new BLA to the U.S. FDA for accelerated approval for datopotamab deruxtecan for treating locally advanced or metastatic epidermal growth factor receptor-mutated non-small-cell lung cancer patients who have received prior systemic therapies.
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China’s NMPA accepts Ascentage NDA for Bcl-2 inhibitor lisaftoclax

Nov. 19, 2024
By Tamra Sami
China’s National Medical Products Administration (NMPA) has accepted Ascentage Pharma Group Corp. Ltd.’s NDA for its in-house-developed Bcl-2 selective inhibitor, lisaftoclax (APG-2575), which could be the first domestically approved Bcl-2 inhibitor in China and the second global approval.
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FDA hands complete response letter to Astellas’ Izervay sNDA

Nov. 19, 2024
By Marian (YoonJee) Chu
The U.S. FDA issued a complete response letter Nov. 15 for Izervay’s (avacincaptad pegol intravitreal solution, ACP) supplemental NDA, which sought to include positive two-year data for the Astellas Pharma Inc. therapy, previously approved for use in a treatment for geographic atrophy secondary to age-related macular degeneration.
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Secondary offering: Syndax wins Revuforj FDA nod in KM2A leukemia

Nov. 18, 2024
By Randy Osborne
Syndax Pharmaceuticals Inc. won U.S. FDA approval – the company’s second this year – for menin inhibitor Revuforj (revumenib) with a black box warning for differentiation syndrome. “We’ve long expected that would be the case,” said CEO Michael Metzger. For “the last six years or so” the agency has had a “heightened awareness” of the problem, and he predicted all drugs in the class would bear similar cautionary language. But there’s also a warning about QT prolongation and a requirement for monitoring.
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